Identity
- Trade Name
- Argyle FDA UDI
- Generic Name
- Tracheostomy care kit, single-use FDA UDI
- Device Name
- Argyle Tracheostomy Care Tray FDA UDI
- Model / Reference
- 47891 FDA UDI
- Description
- Argyle Tracheostomy Care Tray FDA UDI
Identifiers
- Catalog Number
- 47891 FDA UDI
- Primary DI / UDI-DI
- 10192253052985 FDA UDI
- FDA Product Code
- BTO FDA UDI
- GMDN Term
- Tracheostomy care kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Combination Product
Yes
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: Tracheostomy care kit, single-use
Argyle by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy care kit, single-use.
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
- AirLife™ — Airlife, Inc. · Class I
- Resp-O2 Tracheostomy Care Kit, 3-Compartment Tray w/ Vinyl Gloves — Dynarex Corp. · Class I
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- Trinity Sterile, Inc. — TRINITY STERILE, INC. · Class II
- ProCure — Twin Med, LLC · Class I
- AirLife™ — Airlife, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI b53d44e4-f038-4294-be93-5f4a7eb6a08a 35 fields · synced Jun 8, 2026