Identity
- Trade Name
- Typesafe 2.0 FDA UDI
- Generic Name
- Blood donor bag segment sampling IVD FDA UDI
- Device Name
- Typesafe 2.0 - Quantity 500 FDA UDI
- Model / Reference
- SP0201QD FDA UDI
- Description
- Typesafe 2.0 - Quantity 500 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10812269031230 FDA UDI
- FDA Product Code
- KSS FDA UDI
- GMDN Term
- Blood donor bag segment sampling IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9050 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood donor bag segment sampling IVD
Typesafe 2.0 by Typenex Medical, LLC — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood donor bag segment sampling IVD.
- Marketlab Inc — MARKETLAB INC. · Class I
- Marketlab Inc — MARKETLAB INC. · Class I
- Tube-Segment-Opener — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Tube-Segment-Opener Bedside — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Marketlab Inc — MARKETLAB INC. · Class I
- Tube-Segment-Opener — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Marketlab Inc — MARKETLAB INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Typenex Medical, LLC
Sources (2)
- FDA UDI 59a40e29-fc2e-4afd-b6c2-8dd5cb619d2b 34 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 1, 2026