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Device Explorer · FDA GUDID · GMDN 61141

Luer-formatted disinfection cap

A small, noninvasive, closed-ended Luer attachment intended to be attached to a connector in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. I

US‑registered devices54in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Molded Products, Inc.1528%
3M Company1324%
Icu Medical, Inc.1019%
Merit Medical Systems, Inc.815%
Reprocessing Products Corporation24%
Becton, Dickinson And Company24%
Amsino International, Inc.24%
Mckesson Medical-Surgical Inc.24%

Top labelers

CompanyDevicesShare
Molded Products, Inc.1528%
3M Company1324%
Icu Medical, Inc.1019%
Merit Medical Systems, Inc.815%
Reprocessing Products Corporation24%
Becton, Dickinson And Company24%
Amsino International, Inc.24%
Mckesson Medical-Surgical Inc.24%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ICU MedicalClearGuard™SwabTip™SwabCap™SaniGuardRPCBD PureHubMolded Products, Inc.Molded Products, Inc3M™ Curos™Curos™Curos Tips™Curos Jet™Curos™ Tego®AMShield® Disinfecting CapMcKesson

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
PEHHemodialysis Catheter Luer End Cap930
FPASet, Administration, Intravascular15
LKBPad, alcohol, device disinfectant14
QBPCap, device disinfectant10
QBPCap, Device Disinfectant5
FMGStopcock, i.V. Set3

GMDN & GCC registration

  • GMDN code 61141 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 83% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many luer-formatted disinfection cap products are registered in the US?

54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Luer-formatted disinfection cap", from 8 companies. The largest labeler is Molded Products, Inc. with 28% of records.

Which FDA product codes apply?

PEH (Hemodialysis Catheter Luer End Cap), FPA (Set, Administration, Intravascular), LKB (Pad, alcohol, device disinfectant), QBP (Cap, device disinfectant)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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