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Device Product Codes (procodes) for Device Constituent Parts of ANDA/NDA/BLA Combination Products

The table below includes common procodes for device constituent parts of ANDA/NDA/BLA combination products:

Device Constituent Part  Procode Procode Description
Syringe FMF Syringe, Piston
Syringe with Injury Prevention Features MEG Syringe, Antistick
Autoinjector KZH  Introducer, Syringe Needle
Needle-Free Injector, Jet Injector KZE Injector, Fluid, Non-Electrically Powered
Syringe Holder  IQG  Adaptor, Holder, Syringe
Ear, nose, and throat drug administration device KCO  Nasal spray, ENT delivery
Nasal Spray for Systemic Delivery QIY Nasal spray, systemic delivery, CDER or CBER-led
Nebulizer CAF Nebulizer
IV Administration Sets/Kits FPA Set, Administration, Intravascular
IV Tubing FPK Tubing, Fluid Delivery
IV Bag KPE IV Container
Pressure Infusor for IV Bags KZD Infusor, Pressure for IV Bags
IV Transfer Set LHI Set, I.V. Fluid Transfer
Vial Adapter  ONB Closed antineoplastic and hazardous drug reconstitution and transfer system
Medicine Cups KYW Container, Liquid Medication, Graduated
Oral Syringes, Droppers KYX Dispenser, Liquid Medication
Infusion Pumps FRN Pump, Infusion
Insulin Infusion Pumps LZG Pump, Infusion, Insulin
Infusion Pump Accessories MRZ Accessories, Pump, Infusion
Vaginal Applicators HGD  Applicator, Vaginal
Disposable Manual Surgical Instruments (scalpels, clamps, etc.) KDC Instrument, disposable, surgical
Acupuncture Needle MQX Needle, Acupuncture, Single use
Transdermal Delivery System QIX System, transdermal delivery, CDER or CBER-led
Implantable Material for Controlled Release QIZ Material, implantable for controlled release, CDER or CBER-led
Metered Dose Inhaler and Dry Powder Inhaler QKS Inhaler, Metered Dose or Dry Powder, CDER or CBER-led
On-body injector QLF On-Body Injector
Intravaginal system for controlled release of drug substance QLH System, Intravaginal, for Controlled Release of Drug Substance, CDER or CBER-led
Vaporizer QLI Vaporizer, CDER or CBER-led
Pen Injector NSC injector, pen
Enteral Infusion Pump LZH pump, infusion, enteral
Hypodermic Needle FMI needle, hypodermic, single lumen
Infusion line filter FPB filter, infusion line
MDI and nebulizer spacer NVO spacer, direct patient interface
IUD 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) ([email protected]), as well as the Office of Combination Products (OCP) ([email protected]), 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).

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