Bis 186-0137

Bis 186-0137 is a Class II device made by Covidien LP, cleared under FDA 510(k) K093183 on 23 Oct 2009 and listed in FDA GUDID since 4 Oct 2017 (UDI-DI 10884521657793), 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	Number10884521657793 UDI-DI	Date4 Oct 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK093183	Date23 Oct 2009Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10884521657793
FDA 510(k) database 510(k) number K093183

Across registries

2 registries list this device

FDA 510(k) K093183 decided 23 Oct 2009 Active
FDA GUDID UDI-DI 10884521657793 listed 4 Oct 2017 Listed

Timeline

2 dated events

23 Oct 2009 Cleared FDA 510(k) K093183
4 Oct 2017 Listed FDA GUDID 10884521657793

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Bis
Generic name: Cerebral oximeter sensor, single-use
Model / reference: 186-0137

Primary DI / UDI-DI: 10884521657793
510(k) Number: K093183
FDA product code: GXY
GMDN term: Cerebral oximeter sensor, single-use

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)