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Ventlab BT2004

by Ventlab Corp.

Ventlab BT2004 is a Class I device made by Ventlab Corp., cleared under FDA 510(k) K953107 on 15 Aug 1995 and listed in FDA GUDID since 20 Nov 2016 (UDI-DI 10889483081082), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K953107

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10889483081082 UDI-DI Date20 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK953107 Date15 Aug 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K953107 decided 15 Aug 1995 Active
  • FDA GUDID UDI-DI 10889483081082 listed 20 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K953107
  2. Listed FDA GUDID 10889483081082

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ventlab
Generic name
Pulmonary resuscitator, manual, single-use
Model / reference
BT2004
Description
INFANT BAG W/CUSH MASK ,02 RESERVOIR,PEEP ADPT & POP-OFF
Primary DI / UDI-DI
10889483081082
FDA product code
BSJ
GMDN term
Pulmonary resuscitator, manual, single-use
Device class
Class I
Regulation number
868.5550
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 300 Milliliter

Related devices

Category: Pulmonary resuscitator, manual, single-use

Cleared under the same submission (K953107)

and 8 more cleared under K953107

Similar devices in this category

Other devices filed under Pulmonary resuscitator, manual, single-use.

Other devices from Ventlab Corp.

See all devices from Ventlab Corp. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)