Identity
- Trade Name
- Monovette® FDA UDI
- Generic Name
- Blood gas syringe IVD, lithium heparin FDA UDI
- Device Name
- Monovette® 1ml LH blood gas FDA UDI
- Model / Reference
- 05.1146 FDA UDI
- Description
- Monovette® 1ml LH blood gas FDA UDI
Identifiers
- Catalog Number
- 05.1146 FDA UDI
- Primary DI / UDI-DI
- 04038917247221 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Blood gas syringe IVD, lithium heparin 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: Blood gas syringe IVD, lithium heparin
Monovette® by Sarstedt Aktiengesellschaft & Co.KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Blood gas syringe IVD, lithium heparin.
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- 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 480738d9-d8d2-4cb5-b0fd-5120152b3a3c 35 fields · synced Jun 1, 2026