Accutron Inc.
Ref 33025Model Scavenging Circuit
Accutron Inc. (33025) is a breathing circuit bag (EU MDD Class IIa; FDA Class I; FDA product code BTC, Bag, Reservoir) made by Accutron, registered in EUDAMED on 3 Apr 2026 (Basic UDI-DI B-00813830021578) and listed in FDA GUDID since 28 Sep 2016 (UDI-DI 00813830021578), active as of 25 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00813830021578 00813830021578 | Date3 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00813830021578 | Date28 Sep 2016 | StatusListed |
Official records
- EUDAMED public site B-00813830021578
- AccessGUDID record 00813830021578
Across registries
- EUDAMED Basic UDI-DI B-00813830021578 registered 3 Apr 2026 Active
- FDA GUDID UDI-DI 00813830021578 listed 28 Sep 2016 Listed
Timeline
- Listed FDA GUDID 00813830021578
- Registered EUDAMED B-00813830021578
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Accutron Inc. EUDAMEDNon-Latex Resevoir Bag, 3 Liter GUDID
- Generic name
- Breathing circuit bag, reusable
- Model / Ref / Catalog
- Scavenging Circuit, 33025
- Primary DI / UDI-DI
- 00813830021578
- Basic UDI-DI
- B-00813830021578
- FDA product code
- BTC
- EMDN code
- R020199 Breathing circuits and kits - other
- GMDN term
- Breathing circuit bag, reusable
- Device class
- Class IIa EUDAMEDClass I GUDID
- Regulation number
- 868.5320
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000009363
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Similar devices in this category
Other devices filed under BREATHING CIRCUITS AND KITS - OTHER.
- Inflatable Air Cushion Mask, Hook, Size 4, Adult CM-65244 by BESMED HEALTH BUSINESS CORP.
- Ultra-Smt Anesthesia Mask, Size 4, Adult CM-65840 by BESMED HEALTH BUSINESS CORP.
- Neoforce NF-188-1U by FLEXICARE MEDICAL LIMITED
- Infant Resuscitation Kit. T-Piece Circuit NF-157U by FLEXICARE MEDICAL LIMITED
- inspired™ 2096534-002 by VINCENT MEDICAL MANUFACTURING CO., LIMITED
- BiTrac 313-9070 by Pulmodyne Inc.
- MEDIFLEX MFP 614-105 by Mediflex Medikal
- Phasitron® 5 With Unified Connector P5UC by Percussionaire Corporation
- MORTON MEDICAL MN 100-16 PE by Morton Medikal San ve Tic A.Ş.
- Sampling device SV-OSKB (4 Pieces) by Sunvou Medical Electronics Co., Ltd.