BiTrac SE Select 313-9508

by Pulmodyne Inc.

BiTrac SE Select 313-9508 is a Class II device made by Pulmodyne Inc., cleared under FDA 510(k) K023683 on 1 Dec 2003 and listed in FDA GUDID since 30 Sep 2016 (UDI-DI 00841470104467), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841470104467 UDI-DI	Date30 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK023683	Date1 Dec 2003Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00841470104467
FDA 510(k) database 510(k) number K023683

Across registries

2 registries list this device

FDA 510(k) K023683 decided 1 Dec 2003 Active
FDA GUDID UDI-DI 00841470104467 listed 30 Sep 2016 Listed

Timeline

2 dated events

1 Dec 2003 Cleared FDA 510(k) K023683
30 Sep 2016 Listed FDA GUDID 00841470104467

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: BiTrac SE Select
Generic name: CPAP/BPAP face mask, single-use
Model / reference: 313-9508

Primary DI / UDI-DI: 00841470104467
510(k) Number: K023683
FDA product code: BZD
GMDN term: CPAP/BPAP face mask, single-use

Device class: Class II
Regulation number: 868.5905
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under CPAP/BPAP face mask, single-use.

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Properties

Single use
Prescription use
Lot / batch number
Expiration date

Other properties (11, all answered No)