ANESTHESIA ASSOCIATES, INC.

Address:460 Enterprise Street,SAN MARCOS,CA,92078,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

Spirometer, monitoring (w/wo alarm) (BZK) (4) METER, PEAK FLOW, SPIROMETRY (BZH) (3) MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) (CAP) (2) Circuit, breathing (w connector, adaptor, y piece) (CAI) (1)

Premarket Exempt

No Yes

Clear

AincA® - B005001450 Catalog Number : 00-145

Device Description : Respirometer Guard - Fits Mark 8, 14, 25, HS compact & Phys, w/Closure O-Rings, Respirometer Guard - Fits Mark 8, 14, 25, HS compact & Phys, w/Closure O-Rings, Black Neoprene

Device Class : 2

Duns Number: 002065670

Premarket Exempt : Yes

Product Code : BZK

Prescription Use : Yes

Device Count : 1

AincA® - B005001460 Catalog Number : 00-146

Device Description : Respirometer Guard - Fits Fraser-Harlake RM 121 & 311, w/Closure O-Rings, Latex

Device Class : 2

Duns Number: 002065670

Premarket Exempt : Yes

Product Code : BZK

Prescription Use : Yes

Device Count : 1

AincA® - B005001470 Catalog Number : 00-147

Device Description : Respirometer Guard - Fits Mark 12, 20, and Haloscale Standard, w/Closure O-Rings Respirometer Guard - Fits Mark 12, 20, and Haloscale Standard, w/Closure O-Rings, Black Neoprene

Device Class : 2

Duns Number: 002065670

Premarket Exempt : Yes

Product Code : BZK

Prescription Use : Yes

Device Count : 1

AincA® - B005001490 Catalog Number : 00-149

Device Description : Respirometer Guard - Fits Boeringer, w/ Lanyard assembly, Latex

Device Class : 2

Duns Number: 002065670

Premarket Exempt : Yes

Product Code : BZK

Prescription Use : Yes

Device Count : 1

AincA® - B005001500 Catalog Number : 00-150

Device Description : Gauge Guard, Use on all 00-199 (2.5', Bottom/Back Mount) Gauge Products, Mount S Gauge Guard, Use on all 00-199 (2.5', Bottom/Back Mount) Gauge Products, Mount Strip, Blue Alcryn MPR.

Device Class : 2

Duns Number: 002065670

Premarket Exempt : Yes

Product Code : CAP

Prescription Use : Yes

Device Count : 1

AincA® - B00500150BACK0 Catalog Number : 00-150-BACK

Device Description : Gauge Guard for 00-199, 2.5', 1/2" Back and Bottom Mount, Blue, Alcryn MPR Witho Gauge Guard for 00-199, 2.5', 1/2" Back and Bottom Mount, Blue, Alcryn MPR Without Hook and Loop Fastener. Fits 00-199 and related products (LF)

Device Class : 2

Duns Number: 002065670

Premarket Exempt : Yes

Product Code : CAP

Prescription Use : Yes

Device Count : 1

AincA® - B005001640 Catalog Number : 00-164

Device Description : Adapter, Scavenging "T", 19mmM x 19mmM x 19mmM, Chrome Brass

Device Class : 1

Duns Number: 002065670

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

AincA® - B005001730 Catalog Number : 00-173

Device Description : Peak Flow Meter, Std Mini-Wright, 60-800 lpm, SinglePatient, w/Mouthpiece (See 0 Peak Flow Meter, Std Mini-Wright, 60-800 lpm, SinglePatient, w/Mouthpiece (See 00-177/00-281)

Device Class : 2

Duns Number: 002065670

Premarket Exempt : No

Product Code : BZH

Prescription Use : Yes

Device Count : 1

AincA® - B005001740 Catalog Number : 00-174

Device Description : Peak Flow Meter, LowRange Mini-Wright, 30-370 lpm, SinglePatient, w/Mouthpiece ( Peak Flow Meter, LowRange Mini-Wright, 30-370 lpm, SinglePatient, w/Mouthpiece (See 00-176/00-281-P)

Device Class : 2

Duns Number: 002065670

Premarket Exempt : No

Product Code : BZH

Prescription Use : Yes

Device Count : 1

AincA® - B0050017420 Catalog Number : 00-174-2

Device Description : Peak Flow Meter, Trainer, Windmill, fits LowRange Mini-Wright

Device Class : 2

Duns Number: 002065670

Premarket Exempt : No

Product Code : BZH

Prescription Use : Yes

Device Count : 1

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