Identity
- Trade Name
- pNeuton FDA UDI
- Generic Name
- Anaesthesia breathing circuit, single-use FDA UDI
- Device Name
- Neonatal / infant patient circuit, disposable, single patient use, 10 mm ID, 6 foot long each FDA UDI
- Model / Reference
- 58031 FDA UDI
- Description
- Neonatal / infant patient circuit, disposable, single patient use, 10 mm ID, 6 foot long each FDA UDI
Identifiers
- Catalog Number
- 58031 FDA UDI
- Primary DI / UDI-DI
- 00853678006115 FDA UDI
- 510(k) Number
- K121379 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Anaesthesia breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Height — .4 Inch FDA UDIWidth — .4 Inch FDA UDILength — 72 Inch FDA UDIWeight — .394 Pound FDA UDI
Category: Anaesthesia breathing circuit, single-use
pNeuton by Airon Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia breathing circuit, single-use.
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- Portex — ICU MEDICAL, INC. · Class I
- UNIVERSAL FLEX2® — KING SYSTEMS CORPORATION. · Class I
- PEDIATRIC ULTRA FLEX® — KING SYSTEMS CORPORATION. · Class I
Cleared under the same submission
K121379 also covers:
- miniFlow — AIRON CORPORATION
- miniFlow — AIRON CORPORATION
- miniFlow — AIRON CORPORATION
- miniFlow — AIRON CORPORATION
- miniFlow — AIRON CORPORATION
- miniFlow — AIRON CORPORATION
- miniFlow — AIRON CORPORATION
- miniFlow — AIRON CORPORATION
- miniFlow — AIRON CORPORATION
- miniFlow — AIRON CORPORATION
- miniFlow — AIRON CORPORATION
- miniFlow — AIRON CORPORATION
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
- Airon Corporation
Sources (1)
- FDA UDI 9da41340-7593-482c-8fec-da0246092c85 38 fields · synced May 30, 2026