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BD Seditainer™ 0.105M 1.25ml Buffered Sodium Citrate Blood Collection Tubes
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- BD Seditainer™ 0.105M 1.25ml Buffered Sodium Citrate Blood Collection Tubes FDA UDI
- Generic Name
- Evacuated erythrocyte sedimentation rate (ESR) tube IVD FDA UDI
- Device Name
- BD Seditainer™ Buff.Na Citrate 0.105M 1.25ml FDA UDI
- Model / Reference
- 366065 FDA UDI
- Description
- BD Seditainer™ Buff.Na Citrate 0.105M 1.25ml FDA UDI
Identifiers
- Catalog Number
- 366065 FDA UDI
- Primary DI / UDI-DI
- 30382903660651 FDA UDI
- 510(k) Number
- K953994 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
Yes
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
No
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
BD Seditainer™ 0.105M 1.25ml Buffered Sodium Citrate Blood Collection Tubes by Becton, Dickinson U.K. Limited — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Evacuated erythrocyte sedimentation rate (ESR) tube IVD.
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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
- Becton, Dickinson U.K. Limited
Sources (1)
- FDA UDI e95db095-4653-472b-a1c4-2845d953a5d3 36 fields · synced May 30, 2026