Identity
- Trade Name
- e-Delphyn Donor FDA UDI
- Generic Name
- Blood bank information system FDA UDI
- Device Name
- e-Delphyn Donor version 11.x.x (US) FDA UDI
- Model / Reference
- 11(US) FDA UDI
- Description
- e-Delphyn Donor version 11.x.x (US) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007282706 FDA UDI
- FDA Product Code
- MMH FDA UDI
- GMDN Term
- Blood bank information system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9165 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood bank information system
e-Delphyn Donor by Gpi Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Gpi Usa, Inc.
Sources (1)
- FDA UDI 99fbf1c3-72b4-4bdd-80fc-466b51a38004 34 fields · synced May 30, 2026