Identity
- Trade Name
- Emprint SX FDA UDI
- Generic Name
- Non-evacuated blood collection tube IVD, clot activator/separator FDA UDI
- Device Name
- Field Generator FDA UDI
- Model / Reference
- CAFG1 FDA UDI
- Description
- Field Generator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521703223 FDA UDI
- FDA Product Code
- NEY FDA UDIGEI FDA UDI
- GMDN Term
- Non-evacuated blood collection tube IVD, clot activator/separator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-evacuated blood collection tube IVD, clot activator/separator
Emprint SX by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-evacuated blood collection tube IVD, clot activator/separator.
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- S-Monovette® — Sarstedt Aktiengesellschaft & Co.KG · Class II
- BD Microtainer® SST™ — BECTON DICKINSON AND COMPANY · Class II
- SAFE-T-FILL® — Ram Scientific · Class II
- Color Blood Collection Kit (Upper Arm) — COLOR DIAGNOSTICS, LLC · 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
- Covidien LP
Sources (1)
- FDA UDI c5cc2928-3287-43bf-b49a-63f8e8a15ef6 35 fields · synced May 30, 2026