Identity
- Trade Name
- Safety 1st FDA UDI
- Generic Name
- Tongue depressor, examination, reusable FDA UDI
- Device Name
- ESSENTIAL SICK-DAY SCREENING KIT FDA UDI
- Model / Reference
- IH601 FDA UDI
- Description
- ESSENTIAL SICK-DAY SCREENING KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884392954451 FDA UDI
- FDA Product Code
- ERA FDA UDIKYZ FDA UDIFMA FDA UDIFLL FDA UDI
- GMDN Term
- Tongue depressor, examination, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4770 FDA UDI880.6960 FDA UDI880.6230 FDA UDI880.2910 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
No
FDA UDI
Category: Intermittent electronic patient thermometerOtoscope, directNasal aspirator, manualTongue depressor, examination, reusable
Safety 1st by Dorel Juvenile Group, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tongue depressor, examination, reusable.
- TONGUE BLADE HOLDER MINI3000 — Heine Optotechnik GmbH & Co. KG · Class I
- TONGUE BLADE HOLDER DISPOSABLE BLADE — Heine Optotechnik GmbH & Co. KG · Class I
- Quinelato — Schobell Industrial Ltda · Class I
- TONGUE BLADE HOLDER — Heine Optotechnik GmbH & Co. KG · Class I
- Quinelato — Schobell Industrial Ltda · Class I
- TONGUE BLADE HOLDER DISPOSABLE BLADE — Heine Optotechnik GmbH & Co. KG · Class I
- TONGUE BLADE HOLDER — Heine Optotechnik GmbH & Co. KG · Class I
- Safety 1st — DOREL JUVENILE GROUP, INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Dorel Juvenile Group, Inc.
Sources (1)
- FDA UDI 757ee44c-ebfa-43f3-924e-b82b25e3fe05 33 fields · synced Jun 1, 2026