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                Combination Products

Combination Products

                        


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          Combination Products
          Device Product Codes (procodes) for Device Constituent Parts of ANDA/NDA/BLA Combination ProductsCombination Products Device Product Codes (procodes) for Device Constituent Parts of ANDA/NDA/BLA Combination Products
  
  	
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    PrintThe table below includes common procodes1 for device constituent parts of ANDA/NDA/BLA combination products:

Device Constituent Part
			Procode
			Procode DescriptionSyringe
			FMF
			Syringe, PistonSyringe with Injury Prevention Features
			MEG
			Syringe, AntistickAutoinjector
			KZH
			Introducer, Syringe NeedleNeedle-Free Injector, Jet Injector
			KZE
			Injector, Fluid, Non-Electrically PoweredSyringe Holder
			IQG
			Adaptor, Holder, SyringeEar, nose, and throat drug administration device
			KCO
			Nasal spray, ENT deliveryNasal Spray for Systemic Delivery
			QIY
			Nasal spray, systemic delivery, CDER or CBER-ledNebulizer
			CAF
			NebulizerIV Administration Sets/Kits
			FPA
			Set, Administration, IntravascularIV Tubing
			FPK
			Tubing, Fluid DeliveryIV Bag
			KPE
			IV ContainerPressure Infusor for IV Bags
			KZD
			Infusor, Pressure for IV BagsIV Transfer Set
			LHI
			Set, I.V. Fluid TransferVial Adapter
			ONB
			Closed antineoplastic and hazardous drug reconstitution and transfer systemMedicine Cups
			KYW
			Container, Liquid Medication, GraduatedOral Syringes, Droppers
			KYX
			Dispenser, Liquid MedicationInfusion Pumps
			FRN
			Pump, InfusionInsulin Infusion Pumps
			LZG
			Pump, Infusion, InsulinInfusion Pump Accessories
			MRZ
			Accessories, Pump, InfusionVaginal Applicators
			HGD
			Applicator, VaginalDisposable Manual Surgical Instruments (scalpels, clamps, etc.)
			KDC
			Instrument, disposable, surgicalAcupuncture Needle
			MQX
			Needle, Acupuncture, Single useTransdermal Delivery System
			QIX
			System, transdermal delivery, CDER or CBER-ledImplantable Material for Controlled Release
			QIZ
			Material, implantable for controlled release, CDER or CBER-ledMetered Dose Inhaler and Dry Powder Inhaler
			QKS
			Inhaler, Metered Dose or Dry Powder, CDER or CBER-ledOn-body injector
			QLF
			On-Body InjectorIntravaginal system for controlled release of drug substance
			QLH
			System, Intravaginal, for Controlled Release of Drug Substance, CDER or CBER-ledVaporizer
			QLI
			Vaporizer, CDER or CBER-ledPen Injector
			NSC
			injector, penEnteral Infusion Pump
			LZH
			pump, infusion, enteralHypodermic Needle
			FMI
			needle, hypodermic, single lumenInfusion line filter
			FPB
			filter, infusion lineMDI and nebulizer spacer
			NVO
			spacer, direct patient interfaceIUD introducer
			HDT
			device, intrauterine, contraceptive and introducer

FDA maintains a searchable online procode database (that includes both procodes and device common names).  A Combination Product Applicant may contact CDRH’s Division of Industry and Consumer Education (DICE) (DICE@fda.hhs.gov), as well as the Office of Combination Products (OCP) (combination@fda.gov), as needed, for assistance in determining the product code that most closely aligns with their device constituent part.

1 Please note, while this information is helpful for efficient review of ICSRs for all combination products with a device constituent part, selection of a procode for device constituent parts of ANDA/NDA/BLA combination products does not classify the device constituent part within that generic type of device or indicate whether the device constituent part would be classified within that generic type if submitted separately from the drug or biological product in an appropriate device application (see also Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff).

                                                                                  Content current as of:
      02/16/2021Combination Products

          
                        


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