Identity
- Trade Name
- Ambu Hyper System FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- Disposable Hyperinflation System, 1/2L bag (not made with latex), 7' O2 and pressure Lines, Neonatal mask, H2O Pop-off valave FDA UDI
- Model / Reference
- 600 000 615 FDA UDI
- Description
- Disposable Hyperinflation System, 1/2L bag (not made with latex), 7' O2 and pressure Lines, Neonatal mask, H2O Pop-off valave FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05707480137541 FDA UDI
- 510(k) Number
- K932709 FDA UDI
- FDA Product Code
- BZR FDA UDI
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ventilator breathing circuit, single-use
Ambu Hyper System by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K932709 also covers:
- Disposable Hyperinflation System — WESTMED, INC.
- Disposable Medical Hyperinflation System — WESTMED, INC.
- HyperInflation — WESTMED, INC.
- Hyperinflation — WESTMED, INC.
- Hyperinflation — WESTMED, INC.
- Hyperinflation — WESTMED, INC.
- Hyperinflation — WESTMED, INC.
- Hyperinflation — WESTMED, INC.
- Hyperinflation — WESTMED, INC.
- Hyperinflation — WESTMED, INC.
- Hyperinflation — WESTMED, INC.
- Hyperinflation — WESTMED, INC.
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
- Westmed, Inc.
Sources (1)
- FDA UDI ad347d39-8066-4239-9863-ab3a27bbba33 34 fields · synced May 30, 2026