Identity
- Trade Name
- Argyle FDA UDI
- Generic Name
- Oral/respiratory tract specimen container IVD, no additive/medium FDA UDI
- Device Name
- Suction Catheter with Mucus Trap,20 mL FDA UDI
- Model / Reference
- 8888258608 FDA UDI
- Description
- Suction Catheter with Mucus Trap,20 mL FDA UDI
Identifiers
- Catalog Number
- 8888258608 FDA UDI
- Primary DI / UDI-DI
- 10884527000203 FDA UDI
- FDA Product Code
- BSY FDA UDI
- GMDN Term
- Oral/respiratory tract specimen container IVD, no additive/medium FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6810 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 20 Milliliter FDA UDICatheter Gauge — 14 French FDA UDI
Category: Oral/respiratory tract specimen container IVD, no additive/medium
Argyle by Cardinalhealth — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oral/respiratory tract specimen container IVD, no additive/medium.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Salimetrics — SALIMETRICS LLC. · Class I
- Everlywell Saliva Collection Kit — Everly Health, Inc. · Class I
- BD Sputum Collection System — BECTON DICKINSON AND COMPANY · Class I
- Everlywell Blood and Saliva Collection Kit — Everly Health, Inc. · Class II
- Salimetrics — SALIMETRICS LLC. · Class I
- Argyle — Cardinal Health 200, LLC · Class II
- Everlywell Blood and Saliva Collection Kit — Everly Health, Inc. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Cardinalhealth
Sources (1)
- FDA UDI 4fe951e2-902c-4f93-9ed3-84df7ae99d49 36 fields · synced Jun 6, 2026