Bis 150-0037

Bis 150-0037 is a Class II device made by Covidien LP, cleared under FDA 510(k) K041670 on 6 Jul 2004 and listed in FDA GUDID since 15 Aug 2017 (UDI-DI 10884521128538), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10884521128538 UDI-DI	Date15 Aug 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK041670	Date6 Jul 2004Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10884521128538
FDA 510(k) database 510(k) number K041670

Across registries

2 registries list this device

FDA 510(k) K041670 decided 6 Jul 2004 Active
FDA GUDID UDI-DI 10884521128538 listed 15 Aug 2017 Listed

Timeline

2 dated events

6 Jul 2004 Cleared FDA 510(k) K041670
15 Aug 2017 Listed FDA GUDID 10884521128538

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Bis
Generic name: Neurophysiologic monitoring system
Model / reference: 150-0037

Primary DI / UDI-DI: 10884521128538
510(k) Number: K041670
FDA product code: GXY
GMDN term: Neurophysiologic monitoring system

Device class: Class II
Regulation number: 882.1320
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

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Properties

Prescription use
Lot / batch number

Other properties (13, all answered No)