Consulting Wallah › Device Explorer › Other devices › General-body orifice lubricant
Device Explorer · FDA GUDID · GMDN 60796

General-body orifice lubricant

A substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.

US‑registered devices92in commercial distribution
Companies26labelers on GUDID
Single‑use85%of device records
Sterile86%labelled sterile
Prescription12%Rx‑only share
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Share of device records

Hr Pharmaceuticals Inc.2224%
Medline Industries, Inc.67%
Jianerkang Medical Co., Ltd55%
North American Rescue, Llc44%
Prestige Ameritech, Ltd.44%
Bound Tree Medical, Llc44%
Dukal Llc44%
Dynarex Corporation44%

Top labelers

CompanyDevicesShare
Hr Pharmaceuticals Inc.2224%
Medline Industries, Inc.67%
Jianerkang Medical Co., Ltd55%
North American Rescue, Llc44%
Prestige Ameritech, Ltd.44%
Bound Tree Medical, Llc44%
Dukal Llc44%
Dynarex Corporation44%
Resource Optimization & Innovation, L.L.C.44%
Owens & Minor Distribution, Inc.44%
Henry Schein, Inc.44%
Sion Biotext Medical Ltd33%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Sion Biotext Medical Ltd.sterile lubricating jelly / water solubleMedical LubricantMedical Lubricant JellyEndoGlide+™Boston ScientificOPTILUBE BOX OF 150 SACHETSSterile Bacteriostatic Lubricating GelTimm MedicalAQUAGELBoston Scientific Lubricating JellyTruCathHR Lubricating JellySurgilubeHR Lubricating Jelly 2XEZ Lubricating

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

FDA product codes

CodeNameDevices
KMJLubricant, Patient51
KMJLubricant, patient50
FHXJELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT4
NABGauze / Sponge,Nonresorbable For External Use3
OHRCatheter care tray2
PLAEsophageal Thermal Regulation And Gastric Suctioning Device1

GMDN & GCC registration

  • GMDN code 60796 · non‑implantable
  • Single‑use 85% · sterile 86% · Rx‑only 12% · OTC 34%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Gram) · 22Total Volume (Fluid Ounce) · 2Total Volume (Gallon) · 1Total Volume (Milliliter) · 1Catheter Working Length (Centimeter) · 1

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

No closely related category with 50+ devices.

How many general-body orifice lubricant products are registered in the US?

92 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General-body orifice lubricant", from 26 companies. The largest labeler is Hr Pharmaceuticals Inc. with 24% of records.

Which FDA product codes apply?

KMJ (Lubricant, Patient), KMJ (Lubricant, patient), FHX (JELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT), NAB (Gauze / Sponge,Nonresorbable For External Use)

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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