Identity
- Trade Name
- Argyle FDA UDI
- Generic Name
- Infant heat shield FDA UDI
- Device Name
- Adhesive Temperature Probe Cover,Duck & Bear Shaped, Small FDA UDI
- Model / Reference
- 43101 FDA UDI
- Description
- Adhesive Temperature Probe Cover,Duck & Bear Shaped, Small FDA UDI
Identifiers
- Catalog Number
- 43101 FDA UDI
- Primary DI / UDI-DI
- 20884527006554 FDA UDI
- FDA Product Code
- FMT FDA UDI
- GMDN Term
- Infant heat shield FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infant heat shield
Argyle by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infant heat shield.
- MORRISON MEDICAL — MORRISON MEDICAL, LTD · Class I
- Trinity Medical Devices — TRINITY MEDICAL DEVICES INC. · Class I
- Trinity Medical Devices — TRINITY MEDICAL DEVICES INC. · Class I
- Argyle — Cardinalhealth · Class II
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
- Cardinalhealth
Sources (1)
- FDA UDI d9d37df3-f043-41d2-b54b-5e41fb90486c 36 fields · synced May 30, 2026