ATRION MEDICAL PRODUCTS, INC.

Address:1426 CURT FRANCIS RD.,ARAB,AL,35016,US

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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

Dilator, Urethral (KOE) (8) Syringe, Balloon Inflation (MAV) (8) Injector And Syringe, Angiographic (DXT) (2)

Premarket Exempt

Clear

QL Disposable Inflation Device - 00856877002414 Catalog Number : BINF2530

Device Description : Inflation Device Atrion Part Number 96460: 25mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

Encore 40 Inflation Device - 00856877002445 Catalog Number : M001394472540

Device Description : Inflation Device Atrion Part Number 96505: 25ml, 40atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

Vascular Medical Disposable Inflation Device - 00856877002452 Catalog Number : 96470

Device Description : Inflation Device: 20mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

Medtronic Disposable Inflation Device - 00856877002469 Catalog Number : 96473

Device Description : Inflation Device Atrion Part Number 96473: 14mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

QL Fluid Dispensing Syringe - 00856877002476 Catalog Number : 96474

Device Description : Fluid Dispensing Syringe: 20mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

QL Fluid Dispensing Syringe - 00856877002490 Catalog Number : 96476

Device Description : QL Fluid Dispensing Syringe: 4mL, 100psi

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

CRE SteriFlate Disposable Inflation Device - 00856877002506 Catalog Number : M00550630

Device Description : Inflation Device Atrion Part Number 96477: 60mL, 15atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

Bryan Medical, Inc. QL® 2530 Inflation Device - 00856877002513 Catalog Number : 96479

Device Description : Inflation Device: 25mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

OLYMPUS EndoTherapy™ Inflation Device - 00856877002520 Catalog Number : MAJ-1740-D

Device Description : Inflation Device Atrion Part Number 96318: 60mL, 15atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

OLYMPUS EndoTherapy™ Inflation Device for Endoscopic Balloon Dilation - 00856877002537 Catalog Number : MAJ-1740

Device Description : Inflation Device Atrion Part Number 96379: 60mL, 15atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

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