WaisMed Ltd

Address:10 Amal St.,Rosh Haayin Central,IL

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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

Needle, Hypodermic, Single Lumen (FMI) (6) Device, Intravascular Catheter Securement (KMK) (2) Intravenous Extension Tubing Set (OJA) (2) Set, Administration, Intravascular (FPA) (2) Tourniquet, Nonpneumatic (GAX) (2)

Premarket Exempt

No Yes

Clear

NIO - 07290008325028 Catalog Number :

Device Description : The Pediatric NIO device is indicated to provide intraosseous access in the prox The Pediatric NIO device is indicated to provide intraosseous access in the proximal tibia as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age.

Device Class : 2

Duns Number: 514619238

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

B.I.G. - 07290008325035 Catalog Number :

Device Description : The Adult B.I.G. device is indicated to provide intraosseous access into the pro The Adult B.I.G. device is indicated to provide intraosseous access into the proximal tibia and proximal humeral head in adult patients older than 12 years.

Device Class : 2

Duns Number: 514619238

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

B.I.G. - 07290008325042 Catalog Number :

Device Description : The Pediatric B.I.G. device is indicated to provide intraosseous access into the The Pediatric B.I.G. device is indicated to provide intraosseous access into the proximal tibia on children from 0-12 years of age.

Device Class : 2

Duns Number: 514619238

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

NIO - 07290008325059 Catalog Number :

Device Description : The NIO-A device is indicated to provide intraosseous access into the proximal t The NIO-A device is indicated to provide intraosseous access into the proximal tibia and proximal humeral head, in adult patients older than 12 years.

Device Class : 2

Duns Number: 514619238

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

NIO - 07290008325066 Catalog Number :

Device Description : The NIO-Infant (NIO-I) is an intraosseous device intended to provide vascular ac The NIO-Infant (NIO-I) is an intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.

Device Class :

Duns Number: 514619238

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

NIO - 07290008325080 Catalog Number :

Device Description : The NIO Pediatric device is indicated to provide intraosseous access in the prox The NIO Pediatric device is indicated to provide intraosseous access in the proximal tibia as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age.New stabilizer for the pediatric device

Device Class :

Duns Number: 514619238

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

NIO Fixation - 07290008325097 Catalog Number :

Device Class : 1

Duns Number: 514619238

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

GOIO - 17290008325018 Catalog Number :

Device Description : Intraosseous start kit by PerSys Medical

Device Class : 1

Duns Number: 514619238

Premarket Exempt : Yes

Product Code : KMK, GAX, OJA, FPA

Prescription Use : No

Device Count : 1

GOIO - 17290008325100 Catalog Number :

Device Description : Intraosseous start kit by PerSys Medical

Device Class : 1

Duns Number: 514619238

Premarket Exempt : Yes

Product Code : GAX, OJA, FPA

Prescription Use : No

Device Count : 1

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