EINSTEIN WORKS, LLC

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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

Tourniquet, Nonpneumatic (GAX) (5) Needle, Hypodermic, Single Lumen (FMI) (3) Device, Intravascular Catheter Securement (KMK) (1) Intravenous Extension Tubing Set (OJA) (1)

Premarket Exempt

No Yes

Clear

NIO Next Generation IO - 00850026832006 Catalog Number : NIO-P

Device Description : Pediatric NIO Intraosseous

Device Class : 2

Duns Number: 098121274

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

NIO NEXT GENERATION IO - 00850026832020 Catalog Number : NIO-I

Device Description : INFANT NIO INTRAOSSEOUS

Device Class : 2

Duns Number: 098121274

Premarket Exempt : Yes

Product Code : FMI

Prescription Use : Yes

Device Count : 1

NIO NEXT GENERATION IO - 00850026832037 Catalog Number : NIO-A

Device Description : ADULT NIO INTRAOSSEOUS

Device Class : 2

Duns Number: 098121274

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

THE EMERGENCY BANDAGE - 00850026832044 Catalog Number : FCP-09

Device Description : MILITARY ABDOMINAL BANDAGE 8" WIDTH

Device Class : 1

Duns Number: 098121274

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 1

THE EMERGENCY BANDAGE - 00850026832051 Catalog Number : FCP-10T

Device Description : TACTICAL CIVILIAN ABDOMINAL BANDAGE 8" WIDTH

Device Class : 1

Duns Number: 098121274

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 1

THE EMERGENCY BANDAGE - 00850026832068 Catalog Number :

Device Description : WOUNDSTOP HOMECARE

Device Class : 1

Duns Number: 098121274

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 1

THE EMERGENCY BANDAGE - 00850026832075 Catalog Number :

Device Description : WOUNDSTOP CARE 1

Device Class : 1

Duns Number: 098121274

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 1

THE EMERGENCY BANDAGE - 00850026832082 Catalog Number :

Device Description : WOUNDSTOP CARE 1+

Device Class : 1

Duns Number: 098121274

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 1

NIO NEXT GENERATION IO - 00850026832105 Catalog Number :

Device Description : NIO FIXATION DRESSING

Device Class : 1

Duns Number: 098121274

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

GO IO - 00850026832112 Catalog Number : GO IO-F

Device Description : Intraosseous Start Kit w/ Fixation

Device Class : 2

Duns Number: 098121274

Premarket Exempt : Yes

Product Code : OJA

Prescription Use : No

Device Count : 1

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