Identity
- Trade Name
- EXPRESS FDA UDI
- Generic Name
- Cardiotomy reservoir FDA UDI
- Device Name
- EXPRESS II, BRU, SFP (Express Dry Seal Chest Drain - ATS) FDA UDI
- Model / Reference
- 4050-170N FDA UDI
- Description
- EXPRESS II, BRU, SFP (Express Dry Seal Chest Drain - ATS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00650862115161 FDA UDI
- 510(k) Number
- K043140 FDA UDI
- FDA Product Code
- CAC FDA UDI
- GMDN Term
- Cardiotomy reservoir FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5830 FDA UDI
- Commercial Distribution
- Not 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
Express by Atrium Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K043140 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atrium Medical Corp.
Sources (1)
- FDA UDI 73f3f879-d0f3-482c-a7e3-00a0ab0c88e5 35 fields · synced May 30, 2026