Identity
- Trade Name
- Caplugs/Evergreen FDA UDI
- Generic Name
- Oral/respiratory tract specimen container IVD, no additive/medium FDA UDI
- Device Name
- SPUTOCOL SPUTUM COLLECT FRSTND FDA UDI
- Model / Reference
- 221-3995-G80 FDA UDI
- Description
- SPUTOCOL SPUTUM COLLECT FRSTND FDA UDI
Identifiers
- Catalog Number
- 221-3995-G80 FDA UDI
- Primary DI / UDI-DI
- 00810044208122 FDA UDI
- FDA Product Code
- LIO FDA UDI
- GMDN Term
- Oral/respiratory tract specimen container IVD, no additive/medium FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2900 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Oral/respiratory tract specimen container IVD, no additive/medium
Caplugs/Evergreen by Caplugs, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Oral/respiratory tract specimen container IVD, no additive/medium.
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- Salimetrics — SALIMETRICS LLC. · Class I
- Argyle — Cardinal Health 200, LLC · 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
- Caplugs, Inc.
Sources (1)
- FDA UDI e5d3874c-cb0a-4bbd-a67e-2e62b281e3a6 35 fields · synced Jun 9, 2026