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Ultipor™ Anesthesia Breathing Circuit System - Patient Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Ultipor™ Anesthesia Breathing Circuit System - Patient Kit FDA UDI
- Generic Name
- Patient-end respiratory anaesthesia kit FDA UDI
- Device Name
- Medium Vanilla-Scented Adult Face Mask, Ported Elbow, and Ultipor 25 Filter. Non-Conductive, Disposable. FDA UDI
- Model / Reference
- VMPKMA FDA UDI
- Description
- Medium Vanilla-Scented Adult Face Mask, Ported Elbow, and Ultipor 25 Filter. Non-Conductive, Disposable. FDA UDI
Identifiers
- Catalog Number
- VMPKMA FDA UDI
- Primary DI / UDI-DI
- 00636207315304 FDA UDI
- 510(k) Number
- K013093 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Patient-end respiratory anaesthesia kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5260 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
Yes
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: Patient-end respiratory anaesthesia kit
Ultipor™ Anesthesia Breathing Circuit System - Patient Kit by Global Life Sciences Solutions USA LLC — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Patient-end respiratory anaesthesia kit.
- ARC Medical — Typenex Medical, LLC · Class I
- ARC Medical — Typenex Medical, LLC · Class I
- ARC Medical — Typenex Medical, LLC · Class I
- ARC Medical — Typenex Medical, LLC · Class I
- ARC Medical — Typenex Medical, LLC · Class I
- ARC Medical — Typenex Medical, LLC · Class I
- ARC Medical — Typenex Medical, LLC · Class I
- Ultipor™ Anesthesia Breathing Circuit System - Patient Kit — Global Life Sciences Solutions USA LLC · Class II
Cleared under the same submission
K013093 also covers:
- Expandable 15 mm x 5 inch Flex Tube — Global Life Sciences Solutions USA LLC
- Gas Sampling Elbow with Cap — Global Life Sciences Solutions USA LLC
- Latex-free Breathing Bag - 1 Liter — Global Life Sciences Solutions USA LLC
- Latex-free Breathing Bag - 2 Liter — Global Life Sciences Solutions USA LLC
- Latex-free Breathing Bag - 3 Liter — Global Life Sciences Solutions USA LLC
- Ultipor™ 25 Anesthesia Breathing Circuit System Filter — Global Life Sciences Solutions USA LLC
- Ultipor™ 25 Anesthesia Breathing Circuit System Filter — Global Life Sciences Solutions USA LLC
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit — Global Life Sciences Solutions USA LLC
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit — Global Life Sciences Solutions USA LLC
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit — Global Life Sciences Solutions USA LLC
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit — Global Life Sciences Solutions USA LLC
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit — Global Life Sciences Solutions USA LLC
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
- Global Life Sciences Solutions USA LLC
Sources (1)
- FDA UDI 517a30bc-bcbb-4f66-a235-7ccbad212b15 37 fields · synced May 30, 2026