Identity
- Trade Name
- S-Monovette® FDA UDI
- Generic Name
- Non-evacuated blood collection tube IVD, anticoagulant/separator FDA UDI
- Device Name
- S-Monovette® 2.7ml LH-Gel FDA UDI
- Model / Reference
- 04.1928.100 FDA UDI
- Description
- S-Monovette® 2.7ml LH-Gel FDA UDI
Identifiers
- Catalog Number
- 04.1928.100 FDA UDI
- Primary DI / UDI-DI
- 04038917266918 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Non-evacuated blood collection tube IVD, anticoagulant/separator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-evacuated blood collection tube IVD, anticoagulant/separator
S-Monovette® by Sarstedt Aktiengesellschaft & Co.KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-evacuated blood collection tube IVD, anticoagulant/separator.
- SAFE-T-FILL® — Ram Scientific · Class II
- BD Microtainer® PST™ Tubes with LH (Lithium Heparin) - Amber — BECTON DICKINSON AND COMPANY · Class II
- SAFE-T-FILL® — Ram Scientific · Class II
- SAFE-T-FILL® — Ram Scientific · Class II
- BD Microtainer® PST™ Tubes with LH (Lithium Heparin) — BECTON DICKINSON AND COMPANY · Class II
- MiniCollect — Greiner Bio-One GmbH · Class II
- BD Microtainer® Tubes with LH (Lithium Heparin) — BECTON DICKINSON AND COMPANY · Class II
- S-Monovette® — Sarstedt Aktiengesellschaft & Co.KG · 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
- Sarstedt Aktiengesellschaft & Co.KG
Sources (1)
- FDA UDI 2a00d01a-0ea6-4a90-9d62-5bf2fa5093cb 35 fields · synced May 30, 2026