Identity
- Trade Name
- Healthcare Access Terminal FDA UDI
- Generic Name
- Home healthcare information system FDA UDI
- Model / Reference
- 3.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863353000307 FDA UDI
- 510(k) Number
- K113493 FDA UDI
- FDA Product Code
- DRG FDA UDI
- GMDN Term
- Home healthcare information system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Home healthcare information system
Healthcare Access Terminal by Bl Healthcare, 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
- Bl Healthcare, Inc.
Sources (1)
- FDA UDI 662fd37f-e826-461e-9795-440f8fb8e912 33 fields · synced May 30, 2026