Skip to content

BiTrac 313-9075

by Pulmodyne Inc.

Ref 313-9075

BiTrac 313-9075 is a ventilator breathing circuit (EU MDD Class IIa; FDA Class I; FDA product code BZO, Set, Tubing And Support, Ventilator (W Harness)) made by Pulmodyne Inc., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-00841470108168) and listed in FDA GUDID since 3 Mar 2017 (UDI-DI 00841470108168), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841470108168 Basic UDI-DI 00841470108168UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841470108168 UDI-DI Date3 Mar 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841470108168 registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 00841470108168 listed 3 Mar 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841470108168
  2. Registered EUDAMED B-00841470108168

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
BiTrac
Generic name
Ventilator breathing circuit, single-use
Device name
Patient Circuit
Model / reference
313-9075
Primary DI / UDI-DI
00841470108168
Basic UDI-DI
B-00841470108168
FDA product code
BZO
EMDN code
R020199 Breathing circuits and kits - other
GMDN term
Ventilator breathing circuit, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5975
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Ventilator breathing circuit, single-use

Similar devices in this category

Other devices filed under BREATHING CIRCUITS AND KITS - OTHER.

Other devices from Pulmodyne Inc.

See all devices from Pulmodyne Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)