Consulting Wallah › Device Explorer › Procedure kits & trays › Oral care kit, single-use
Device Explorer · FDA GUDID · GMDN 45172

Oral care kit, single-use

A collection of various devices and supplies used for a patient's oral hygiene. It typically includes an antiseptic applicator swab, a pre-treated toothbrush, mouth swabs, and a mouthwash/oral moisturizer. Its use will improve the physical condition of the ora

US‑registered devices292in commercial distribution
Companies13labelers on GUDID
Single‑use95%of device records
Sterile8%labelled sterile
Prescription24%Rx‑only share
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Share of device records

Trademark Medical, L.L.C.13446%
Avanos Medical, Inc.5720%
Sunmed, Llc3412%
Trinity Sterile, Inc.176%
Centurion Medical Products Corporation155%
Sage Products, Llc103%
Apollo Medical Products Corp.83%
Medline Industries, Inc.62%

Top labelers

CompanyDevicesShare
Trademark Medical, L.L.C.13446%
Avanos Medical, Inc.5720%
Sunmed, Llc3412%
Trinity Sterile, Inc.176%
Centurion Medical Products Corporation155%
Sage Products, Llc103%
Apollo Medical Products Corp.83%
Medline Industries, Inc.62%
Intersurgical Incorporated52%
Medical Action Industries Inc.31%
Smd Manufacturing Llc10%
National Distribution & Contracting, Inc.10%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Q-CareOROCARE™ SUCTION CONTROL VALVE, FLEXIBLE – FLEXIOROCARE ASPIRE SUCTION TOOTHBRUSHOROCARE SENSITIVE ORAL SUCTION WANDSUCTION LINE SPLITTERReddyPortSterling Medical ProductsCenturionQUALASageToothette Oral CareAVANOSBallard* 24-Hour Oral Care KitBALLARDAVANOS*Ballard* Assisted Care 24-Hour Oral Care Kit

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

FDA product codes

CodeNameDevices
NXZDental Hygiene Kit134
JOLCATHETER AND TIP, SUCTION42
NSBPatient personal hygiene kit29
KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE28
NXZDental hygiene kit19
LROGeneral surgery tray18

GMDN & GCC registration

  • GMDN code 45172 · non‑implantable
  • Single‑use 95% · sterile 8% · Rx‑only 24% · OTC 5%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 8

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

No closely related category with 50+ devices.

How many oral care kit, single-use products are registered in the US?

292 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Oral care kit, single-use", from 13 companies. The largest labeler is Trademark Medical, L.L.C. with 46% of records.

Which FDA product codes apply?

NXZ (Dental Hygiene Kit), JOL (CATHETER AND TIP, SUCTION), NSB (Patient personal hygiene kit), KXF (APPLICATOR, ABSORBENT TIPPED, NON-STERILE)

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.

How do I get quotes?

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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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