Identity
- Trade Name
- Argyle FDA UDI
- Generic Name
- Infant heat shield FDA UDI
- Device Name
- Adhesive Temperature Probe Cover,Duck & Bear Shaped,Large FDA UDI
- Model / Reference
- 43102 FDA UDI
- Description
- Adhesive Temperature Probe Cover,Duck & Bear Shaped,Large FDA UDI
Identifiers
- Catalog Number
- 43102 FDA UDI
- Primary DI / UDI-DI
- 20884527006561 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 |
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Manufacturer
- Manufacturer
- Cardinalhealth
Sources (1)
- FDA UDI 72f23d96-0d18-4548-be8e-1d1446d08f19 36 fields · synced Jun 6, 2026