WESTERN/SCOTT FETZER COMPANY

Address:875 Bassett Rd,Westlake,OH,44145,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Regulator, Pressure, Gas Cylinder (CAN) (7) Tubing, Pressure And Accessories (BYX) (2) Yoke Assembly, Medical Gas (CAM) (1)

Premarket Exempt

Yes

Clear

Western/Scott Fetzer - B929N4SUY300FHTFHT0 Catalog Number : N4SUY300FHTFHT

Device Description : PKGD: N4-SUC-300-FHT-FHT CAN

Device Class : 1

Duns Number: 148634731

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

Western/Scott Fetzer - B929N4SUY360FHTMBA0 Catalog Number : N4SUY360FHTMBA

Device Description : PKGD: N4-SUC-360-FHT-MBA CAN

Device Class : 1

Duns Number: 148634731

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

Western/Scott Fetzer - B929NAS76250 Catalog Number : NAS-7625

Device Description : REGULATOR (M1) PRESET CGA 950

Device Class : 1

Duns Number: 148634731

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : Yes

Device Count : 1

Western/Scott Fetzer - B929NMR87015FM0 Catalog Number : NMR-870-15FM

Device Description : 0-15LPM O2 FM/REG/MR CONDITONL

Device Class : 1

Duns Number: 148634731

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : Yes

Device Count : 1

Western/Scott Fetzer - B929NMR870P0 Catalog Number : NMR-870-P

Device Description : 50PSI PRESET REG/870/ MR COND.

Device Class : 1

Duns Number: 148634731

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : Yes

Device Count : 1

DATEX-OHMEDA - B929OMA86520 Catalog Number : OMA-8652

Device Description : 1009-3036-000/ M91-4 PVT LABEL

Device Class :

Duns Number: 148634731

Premarket Exempt : Yes

Product Code : CAM

Prescription Use : Yes

Device Count : 1

Western/Scott Fetzer - B929OPA5100 Catalog Number : OPA-510

Device Description : PKGD: O2 REG 1/64-2LPM/CGA 540

Device Class : 1

Duns Number: 148634731

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : Yes

Device Count : 1

Western/Scott Fetzer - B929OPA5200 Catalog Number : OPA-520

Device Description : PKGD: O2 REG 1/4-15LPM/CGA 540

Device Class : 1

Duns Number: 148634731

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : Yes

Device Count : 1

Western/Scott Fetzer - B929OPA5400 Catalog Number : OPA-540

Device Description : PKGD: O2 REG .5-8 LPM/ CGA 540

Device Class : 1

Duns Number: 148634731

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : Yes

Device Count : 1

Western/Scott Fetzer - B929OPA8100 Catalog Number : OPA-810

Device Description : PKGD: O2 REG 1/64-2LPM CGA 870

Device Class : 1

Duns Number: 148634731

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : Yes

Device Count : 1

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