Identity
- Trade Name
- FRU, WAGD Vacuum Hose FDA UDI
- Generic Name
- Oxygen/air/nitrous oxide breathing gas mixer FDA UDI
- Model / Reference
- 27397 FDA UDI
Identifiers
- Catalog Number
- 27397 FDA UDI
- Primary DI / UDI-DI
- 00813830021103 FDA UDI
- 510(k) Number
- K033503 FDA UDI
- FDA Product Code
- CBN FDA UDI
- GMDN Term
- Oxygen/air/nitrous oxide breathing gas mixer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5430 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
FRU, WAGD Vacuum Hose by Accutron — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K033503 also covers:
- Accu-Vac — ACCUTRON
- Accutron EZ Vacuum Male Connector — ACCUTRON
- Accutron Vacuum Male Connector — ACCUTRON
- Adaptor, ClearView To Matrx — ACCUTRON
- CM Installation Kit, RFS — ACCUTRON
- CV Scavenging Circuit, Basic Replacement — ACCUTRON
- Canisters, 5 Disposable — ACCUTRON
- Chemtron Vacuum Male Connector — ACCUTRON
- FRU, 4 Cylinder Remote Vacuum Kit — ACCUTRON
- FRU, Check Valve Vacuum — ACCUTRON
- FRU, InLine Vacuum Controller — ACCUTRON
- FRU, Scavenger Hub, EU — ACCUTRON
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
- Accutron
Sources (1)
- FDA UDI e334d9f4-63ce-4db4-80ae-c22b9571cdd1 35 fields · synced May 31, 2026