Identity
- Trade Name
- Safety 1st FDA UDI
- Generic Name
- Infant care kit FDA UDI
- Model / Reference
- IH474 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884392625023 FDA UDI
- 510(k) Number
- K101387 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infant care kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infant care kit
Safety 1st by Dorel Juvenile Group, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infant care kit.
- Kit, Anesthesia Assembly Phoebe *8/L — PACKROOM LLC
- KIT, FLOYD CATH + BIODOME — PACKROOM LLC
- Ladybug Silicone Breast Milk Collectors (75ml) - 2pcs — THINK GREEN LIMITED · Class I
- Summer Infant — SUMMER INFANT (USA), INC. · Class II
- Dr. Brown's — Dr. Brown's Company · Class I
- Summer Infant — SUMMER INFANT (USA), INC. · Class II
- Kit, Ped Intub Pink/Red 6-9kg NGHS — PACKROOM LLC
- Dr. Brown's — Dr. Brown's Company · Class I
Cleared under the same submission
K101387 also covers:
- ADVOCATE ORAL & RECTAL THERMOMETER — DIABETIC SUPPLY OF SUNCOAST, INC.
- Safety 1st — DOREL JUVENILE GROUP, INC.
- Safety 1st — DOREL JUVENILE GROUP, INC.
- Safety 1st — DOREL JUVENILE GROUP, INC.
- Safety 1st — DOREL JUVENILE GROUP, INC.
- Safety 1st — DOREL JUVENILE GROUP, INC.
- Safety 1st — DOREL JUVENILE GROUP, INC.
- FDK — Fudakang Industrial Co., Ltd.
- FDK — Fudakang Industrial Co., Ltd.
- FDK — Fudakang Industrial Co., Ltd.
- FDK — Fudakang Industrial Co., Ltd.
- FDK — Fudakang Industrial Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dorel Juvenile Group, Inc.
Sources (1)
- FDA UDI 0f734e47-a035-453e-a78c-a3b0858b8944 33 fields · synced May 30, 2026