Device Explorer · FDA GUDID · GMDN 10243

Infant care kit

A portable collection of devices and supplies designed to assist in the care of an infant/baby that typically includes two or more of the following: a thermometer, medical measuring spoon/dropper, nasal aspirator, irrigation saline solution, a teether, and nai

US‑registered devices202in commercial distribution
Companies15labelers on GUDID
Single‑use24%of device records
Sterile26%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Dorel Juvenile Group, Inc.9547%
Packroom Llc4020%
Think Green Limited3919%
Mam Usa Corporation63%
Manus Medical, Llc63%
Summer Infant (Usa), Inc.42%
Supermouth Llc31%
Tomy International, Inc.21%

Top labelers

CompanyDevicesShare
Dorel Juvenile Group, Inc.9547%
Packroom Llc4020%
Think Green Limited3919%
Mam Usa Corporation63%
Manus Medical, Llc63%
Summer Infant (Usa), Inc.42%
Supermouth Llc31%
Tomy International, Inc.21%
Ashtel Studios, Inc10%
Asp Global, Llc10%
Walgreen Co.10%
Drive Devilbiss Healthcare10%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Safety 1stPeekaboo Teething RingBaby Bristles TeetherBaby Bristle RattleSmart CareMAMNORTHSIDE HOSPITALPack, ENT BradleyKit, Ped Intub Gray 3-5kg NGHSPack, CABG KennestoneNEGA Lithotomy RFID PackPack, Angio HamiltonKennestone Upper Extremity PackPack, Basic NEGA *RFIDKit, Ped Nurse Yellow 12-14kg NGHSKit, Ped Intub Yellow 12-14kg NGHS

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

FDA product codes

CodeNameDevices
FLLThermometer, Electronic, Clinical102
MEFRing, Teething, Non-Fluid Filled32
PWABreast Pump Accessory, Milk Expression Aid, Via Positive Pre26
KKORing, Teething, Fluid-Filled12
OKVObstetrical Kit4
FLLThermometer, electronic, clinical4

GMDN & GCC registration

  • GMDN code 10243 · non‑implantable
  • Single‑use 24% · sterile 26% · Rx‑only 3% · OTC 12%
  • 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.

No closely related category with 50+ devices.

How many infant care kit products are registered in the US?

202 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Infant care kit", from 15 companies. The largest labeler is Dorel Juvenile Group, Inc. with 47% of records.

Which FDA product codes apply?

FLL (Thermometer, Electronic, Clinical), MEF (Ring, Teething, Non-Fluid Filled), PWA (Breast Pump Accessory, Milk Expression Aid, Via Positive Pre), KKO (Ring, Teething, Fluid-Filled)

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?

Add infant care kit to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

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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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