Identity
- Trade Name
- Babi.Plus FDA UDI
- Generic Name
- Ventilator IMV supplemental circuit, single-use FDA UDI
- Device Name
- Distributed by Teleflex FDA UDI
- Model / Reference
- BC23-HD FDA UDI
- Description
- Distributed by Teleflex FDA UDI
Identifiers
- Catalog Number
- 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port FDA UDI
- Primary DI / UDI-DI
- 04710810100802 FDA UDI
- 510(k) Number
- K110383 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- Ventilator IMV supplemental circuit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ventilator IMV supplemental circuit, single-use
Babi.Plus by Galemed Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ventilator IMV supplemental circuit, single-use.
- SAVe1 Conversion Kit — SAFEGUARD US OPERATING, LLC · Class I
- Babi.Plus — Galemed Corp. · 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
- Galemed Corp.
Sources (1)
- FDA UDI 013bd926-8578-4a56-aa77-26aa281f20c0 35 fields · synced May 30, 2026