Precision Medical, Inc.

Address:300 HELD DR.,NORTHAMPTON,PA,18067,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, Vacuum (KDP) (5) Mixer, Breathing Gases, Anesthesia Inhalation (BZR) (3) Generator, Oxygen, Portable (CAW) (2)

Premarket Exempt

No Yes

Clear

Precision Medical Inc. - 00855887006047 Catalog Number :

Device Description : PM5400 SERIES,BLENDER,HE/O2,LOW FLOW,70/30

Device Class : 2

Duns Number: 112569116

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Precision Medical Inc. - 00855887006054 Catalog Number :

Device Description : PM5400 SERIES,BLENDER,HE/O2,LOW FLOW,80/20

Device Class : 2

Duns Number: 112569116

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Precision Medical Inc. - 00855887006061 Catalog Number :

Device Description : BLENDER ASSY,AIRON,MRI,LF

Device Class : 2

Duns Number: 112569116

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Precision Medical Inc. - 00855887006078 Catalog Number :

Device Description : PM4150 SERIES,CONCENTRATOR,OXYGEN,PORTABLE, 5 LITER

Device Class : 2

Duns Number: 112569116

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Precision Medical Inc. - 00855887006085 Catalog Number :

Device Description : PM4130 SERIES,CONCENTRATOR,OXYGEN,PORTABLE,3 LITER

Device Class : 2

Duns Number: 112569116

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Precision Medical Inc. - 00855887006092 Catalog Number :

Device Description : PM3300 SERIES,VAC REG,INTERMITTENT,200MMHG

Device Class : 2

Duns Number: 112569116

Premarket Exempt : No

Product Code : KDP

Prescription Use : Yes

Device Count : 1

Precision Medical Inc. - 00855887006108 Catalog Number :

Device Description : PM3400 SERIES,VAC REG,INTERMITTENT,150MMHG

Device Class : 2

Duns Number: 112569116

Premarket Exempt : No

Product Code : KDP

Prescription Use : Yes

Device Count : 1

Precision Medical Inc. - 00855887006115 Catalog Number :

Device Description : PM3000 SERIES,VAC REG,CONT,2POSN,200MMHG

Device Class : 2

Duns Number: 112569116

Premarket Exempt : No

Product Code : KDP

Prescription Use : Yes

Device Count : 1

Precision Medical Inc. - 00855887006122 Catalog Number :

Device Description : PM3100 SERIES,VAC REG,CONT,3POSN,200MMHG

Device Class : 2

Duns Number: 112569116

Premarket Exempt : No

Product Code : KDP

Prescription Use : Yes

Device Count : 1

Precision Medical Inc. - 00855887006139 Catalog Number :

Device Description : PM3200E SERIES,VAC REG,CONT,2POSN,100KPA

Device Class : 2

Duns Number: 112569116

Premarket Exempt : No

Product Code : KDP

Prescription Use : Yes

Device Count : 1

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