Pro1tek

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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

Kit, First Aid, Talking (OVR) (7) First Aid Kit Without Drug (OHO) (3)

Premarket Exempt

No Yes

Clear

EMPACT 6+ Patient Hard Case Kit with Wall Cabinet - B28300 Catalog Number :

Device Description : EMPACT 6+ Patient Hard Case Kit with Wall Cabinet - 6+ Patient Kit with Bat Fla

Device Class : 1

Duns Number: 827067880

Premarket Exempt : Yes

Product Code : OVR

Prescription Use : No

Device Count : 1

PRO1TEK Trauma First Aid Bleeding Control Kit - Vehicle Kit - B283CTKOST10 Catalog Number :

Device Description : PRO1TEK Medical Trauma First Aid Bleeding Control Kit- 1+ Patient with SWAT Tour

Device Class : 1

Duns Number: 827067880

Premarket Exempt : No

Product Code : OVR

Prescription Use : No

Device Count : 1

PRO1TEK 2+ Patient IFAK Kit - B283E1BB0 Catalog Number :

Device Description : PRO1TEK 2+ Patient IFAK Kit with Wound Spray, Bleeding Control tools with Hemost

Device Class : 1

Duns Number: 827067880

Premarket Exempt : No

Product Code : OVR

Prescription Use : No

Device Count : 1

PRO1TEK Trauma First Aid Advanced Kit- 1+ Patient - B283E1SBDPDBP0 Catalog Number :

Device Description : PRO1TEK Medical Trauma First Aid Advanced Bleeding Kit- 1 + Patient with Hemosta

Device Class : 1

Duns Number: 827067880

Premarket Exempt : No

Product Code : OVR

Prescription Use : Yes

Device Count : 1

PRO1TEK Trauma First Aid Bleeding Kit - 1+ Patient with C.A.T. - B283E1TCOB0 Catalog Number :

Device Description : PRO1TEK Trauma First Aid Bleeding Kit- 1+ Patient with C.A.T. Tourniquet

Device Class : 1

Duns Number: 827067880

Premarket Exempt : No

Product Code : OHO

Prescription Use : No

Device Count : 1

PRO1TEK Trauma First Aid Bleeding Control Kit- 1+ Patient with SWAT T - B283E1TCOD0 Catalog Number :

Device Description : PRO1TEK Medical Trauma First Aid Bleeding Control Kit- 1+ Patient with SWAT Tourniquet

Device Class : 1

Duns Number: 827067880

Premarket Exempt : No

Product Code : OHO

Prescription Use : No

Device Count : 1

PRO1TEK Trauma First Aid Advanced Bleeding Kit- 1+ Patient with C.A.T. - B283E1TCPB0 Catalog Number :

Device Description : PRO1TEK Medical Trauma First Aid Advanced Bleeding Kit - 1+ Patient with C.A.T.

Device Class : 1

Duns Number: 827067880

Premarket Exempt : No

Product Code : OVR

Prescription Use : Yes

Device Count : 1

PRO1TEK Trauma First Aid Advanced Bleeding Control Kit- 1+ Patient with SWAT T - B283E1TCPD0 Catalog Number :

Device Description : PRO1TEK Medical Trauma First Aid Advanced Bleeding Control Kit - 1+ Patient Toss

Device Class : 1

Duns Number: 827067880

Premarket Exempt : No

Product Code : OVR

Prescription Use : Yes

Device Count : 1

PRO1TEK Trauma First Aid Bleeding Control Kit-2+ Patient IFAK w/ BC - B283E2IFBOD0 Catalog Number :

Device Description : PRO1TEK Medical Trauma First Aid Bleeding Control Kit- 2+ Patient IFAK with Burn Cream

Device Class : 1

Duns Number: 827067880

Premarket Exempt : No

Product Code : OHO

Prescription Use : No

Device Count : 1

PRO1TEK Trauma First Aid Advanced Bleeding Control- 2+ Patient IFAK - B283E2IFBPC0 Catalog Number :

Device Description : PRO1TEK 2+ Patient Advanced Bleeding Control IFAK Kit / with extra Hemostatic Dressing

Device Class : 1

Duns Number: 827067880

Premarket Exempt : No

Product Code : OVR

Prescription Use : Yes

Device Count : 1

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