AXIOM MEDICAL, INCORPORATED

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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

Catheter, Ventricular, General & Plastic Surgery (GBS) (5) Tubing, Noninvasive (GAZ) (5)

Premarket Exempt

No Yes

Clear

Axiom® - M665512NS0 Catalog Number :

Device Description : Non Sterile Continuous Tubing

Device Class :

Duns Number: 094439676

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

Axiom® - M665513NS0 Catalog Number :

Device Description : Non Sterile Continuous Tubing

Device Class : 2

Duns Number: 094439676

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

Axiom® - M665514NS0 Catalog Number :

Device Description : Non Sterile Continuous Tubing

Device Class : 2

Duns Number: 094439676

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

Axiom® - M665515NS0 Catalog Number :

Device Description : Non Sterile Continuous Tubing

Device Class : 2

Duns Number: 094439676

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

Axiom® - M665516NS0 Catalog Number :

Device Description : Non Sterile Continuous Tubing

Device Class :

Duns Number: 094439676

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

Axiom® PVC - M6655222080 Catalog Number :

Device Description : Thoracic Catheter, Right Angle PVC

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBS

Prescription Use : Yes

Device Count : 1

Axiom® PVC - M6655222100 Catalog Number :

Device Description : Thoracic Catheter, Straight, PVC, With Trocar

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBS

Prescription Use : Yes

Device Count : 1

Axiom® PVC - M6655222120 Catalog Number :

Device Description : Thoracic Catheter, Straight, PVC, With Trocar

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBS

Prescription Use : Yes

Device Count : 1

Axiom® PVC - M6655222160 Catalog Number :

Device Description : Thoracic Catheter, Straight, PVC, With Trocar

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBS

Prescription Use : Yes

Device Count : 1

Axiom® PVC - M6655222200 Catalog Number :

Device Description : Thoracic Catheter, Straight, PVC, With Trocar

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBS

Prescription Use : Yes

Device Count : 1

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