Identity
- Trade Name
- A200SP Absorber MRI FDA UDI
- Generic Name
- Anaesthesia breathing circuit, reusable FDA UDI
- Device Name
- Anaesthesia Absorber for use in MRI environment and all clinical environments. FDA UDI
- Model / Reference
- A200SP FDA UDI
- Description
- Anaesthesia Absorber for use in MRI environment and all clinical environments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051977000109 FDA UDI
- FDA Product Code
- BSF FDA UDI
- GMDN Term
- Anaesthesia breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5310 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Anaesthesia breathing circuit, reusable
A200SP Absorber MRI by Penlon , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia breathing circuit, reusable.
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit — Global Life Sciences Solutions USA LLC · Class II
- MATRX SCAV, W/SM HOOD(WO/SHUTOF — Parker Hannifin Corp. · Class I
- AirTechniques — Baldus Sedation GmbH & Co. KG · Class I
- Sil.Plus — Galemed Corp. · Class I
- PORTER/BRN ADULT RG ASSY ONLY — Parker Hannifin Corp. · Class I
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit — Global Life Sciences Solutions USA LLC · Class II
- 30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER ELBOW, AND LIMB, 2.4M — Intersurgical Incorporated · Class I
- Ultipor™ Anesthesia Breathing Circuit System - Pediatric Machine Kit — Global Life Sciences Solutions USA LLC · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Penlon , Ltd.
Sources (1)
- FDA UDI 3e211df9-d9da-4d5f-83fc-ebc830fec492 33 fields · synced May 30, 2026