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VSE8004XD - Empty Bag 600 mL 6-Way Man
FDA UDIClass II (US FDA UDI)
by Maco Pharma
Identity
- Trade Name
- VSE8004XD - Empty Bag 600 mL 6-Way Man FDA UDI
- Generic Name
- Blood donor set, single-pack FDA UDI
- Device Name
- 600 mL Empty Bag for Pooling of Blood Components. FDA UDI
- Model / Reference
- VSE FDA UDI
- Description
- 600 mL Empty Bag for Pooling of Blood Components. FDA UDI
Identifiers
- Catalog Number
- VSE8004XD FDA UDI
- Primary DI / UDI-DI
- 03567050069687 FDA UDI
- FDA Product Code
- CAK FDA UDI
- GMDN Term
- Blood donor set, single-pack FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
Yes
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
Yes
FDA UDI
Category: Blood donor set, single-pack
VSE8004XD - Empty Bag 600 mL 6-Way Man by Maco Pharma — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood donor set, single-pack.
- NAR — NORTH AMERICAN RESCUE, LLC. · Class II
- NAR Kit — NORTH AMERICAN RESCUE, LLC.
- Fresh Whole Blood Donor Transfusion Set — SAFEGUARD US OPERATING, LLC
- NAR — NORTH AMERICAN RESCUE, LLC. · Class II
- Fresh Whole Blood Donor Transfusion Set — SAFEGUARD US OPERATING, LLC · Class II
- Fresh Whole Blood Transfusion Set — SAFEGUARD US OPERATING, LLC · Class II
- Fresh Whole Blood Donor Transfusion Set — SAFEGUARD US OPERATING, LLC · Class II
- Haemonetics — HAEMONETICS CORPORATION · Class II
Cleared under the same submission
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
- Maco Pharma
Sources (1)
- FDA UDI d09b2a80-f88e-4fc6-9590-c8d08fbdc633 36 fields · synced May 30, 2026