Identity
- Trade Name
- FRU, 4 Cylinder Remote Vacuum Kit FDA UDI
- Generic Name
- Anaesthesia workstation gas scavenger FDA UDI
- Model / Reference
- 28326-FRU FDA UDI
Identifiers
- Catalog Number
- 28326-FRU FDA UDI
- Primary DI / UDI-DI
- 00813830027839 FDA UDI
- 510(k) Number
- K033503 FDA UDI
- FDA Product Code
- CBN FDA UDI
- GMDN Term
- Anaesthesia workstation gas scavenger FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5430 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
Yes
FDA UDI
Category: Anaesthesia workstation gas scavenger
FRU, 4 Cylinder Remote Vacuum Kit by Accutron — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia workstation gas scavenger.
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- BLOCK, SCAV-DIGITAL MDM(STAND M — Parker Hannifin Corp. · Class I
- NITRONOX SCAVENGER HD — Parker Hannifin Corp. · Class II
- NITRONOX SCAVENGER, 2 CYL.CART — Parker Hannifin Corp. · Class II
- NITRONOX SCAVENGER, WALL MOUNT — Parker Hannifin Corp. · Class II
- SCAVENGER SUB-ASSY, SEN SEDATE — Parker Hannifin Corp. · Class II
- Dynamic Gas Scavenging System — Anesthetic Gas Reclamation, Inc. · Class II
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, Check Valve Vacuum — ACCUTRON
- FRU, InLine Vacuum Controller — ACCUTRON
- FRU, Scavenger Hub, EU — ACCUTRON
- FRU, Scavenging Plug — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Accutron
Sources (1)
- FDA UDI 5bde33e5-65ff-4b90-9b5a-2c04198a0069 34 fields · synced Jun 1, 2026