Identity
- Trade Name
- Micro tube 1.3ml FH FDA UDI
- Generic Name
- Non-evacuated blood collection tube IVD, anticoagulant/antiglycolytic FDA UDI
- Model / Reference
- 41.1394.105 FDA UDI
Identifiers
- Catalog Number
- 41.1394.105 FDA UDI
- Primary DI / UDI-DI
- 04038917128353 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Non-evacuated blood collection tube IVD, anticoagulant/antiglycolytic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-evacuated blood collection tube IVD, anticoagulant/antiglycolytic
Micro tube 1.3ml FH by Sarstedt Aktiengesellschaft & Co.KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Non-evacuated blood collection tube IVD, anticoagulant/antiglycolytic.
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- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Sarstedt Aktiengesellschaft & Co.KG
Sources (1)
- FDA UDI ce8ad251-84fb-4a11-a590-df1f568c6248 34 fields · synced Jun 6, 2026