Identity
- Trade Name
- S-Sedivette® FDA UDI
- Generic Name
- Evacuated erythrocyte sedimentation rate (ESR) tube IVD FDA UDI
- Device Name
- S-Sedivette® 3.5ml 4NC FDA UDI
- Model / Reference
- 06.1690.100 FDA UDI
- Description
- S-Sedivette® 3.5ml 4NC FDA UDI
Identifiers
- Catalog Number
- 06.1690.100 FDA UDI
- Primary DI / UDI-DI
- 04038917133128 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Evacuated erythrocyte sedimentation rate (ESR) tube IVD 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: Evacuated erythrocyte sedimentation rate (ESR) tube IVD
S-Sedivette® by Sarstedt Aktiengesellschaft & Co.KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- BD Vacutainer® ESR Blood Collection Tubes — BECTON DICKINSON AND COMPANY · 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 c467671f-f30c-4d40-afe2-9310cc550fff 35 fields · synced May 30, 2026