Identity
- Trade Name
- Biosphere® lid chain, flat FDA UDI
- Generic Name
- Test tube/reservoir cap IVD FDA UDI
- Model / Reference
- 65.989 FDA UDI
Identifiers
- Catalog Number
- 65.989 FDA UDI
- Primary DI / UDI-DI
- 04038917281485 FDA UDI
- FDA Product Code
- KDT FDA UDI
- GMDN Term
- Test tube/reservoir cap IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 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: Test tube/reservoir cap IVD
Biosphere® lid chain, flat by Sarstedt Aktiengesellschaft & Co.KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Test tube/reservoir cap IVD.
- Monoject — Cardinal Health 200, LLC · Class II
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- MDHC — MDHC Life Technologies (Kunshan) Co., LTD. · Class I
- Biosphere® Screw Cap, red — Sarstedt Aktiengesellschaft & Co.KG · Class I
- S-CAP, O-RING, F/SC MTUBE, BLK — Sarstedt Aktiengesellschaft & Co.KG · Class I
- S-CAP, O-RING, F/SC MTUBE — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Screw cap, red — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Twist cap for Microvette® — Sarstedt Aktiengesellschaft & Co.KG · Class I
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 a7e1706a-7a6d-4b4e-b079-a56390fdce37 34 fields · synced May 31, 2026