INNOVATIONS FOR ACCESS INC

Address:8531 NE Cornell Rd,Hillsboro,OR,97124,US

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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

Accessories, Blood Circuit, Hemodialysis (KOC) (3)

Premarket Exempt

Clear

HemoBand - 00865165000209 Catalog Number : HB-NSXL

Device Description : HemoBand Non-Sterile XL HB-NSXL (Extra Long Length - 17")

Device Class : 2

Duns Number: 051632466

Premarket Exempt : No

Product Code : KOC

Prescription Use : Yes

Device Count : 1

HemoBand - 00865165000216 Catalog Number : HB-NS

Device Description : HemoBand Non-Sterile HB-NS (Standard Length - 14")

Device Class : 2

Duns Number: 051632466

Premarket Exempt : No

Product Code : KOC

Prescription Use : Yes

Device Count : 1

HemoBand - 00865165000223 Catalog Number : HB-1M

Device Description : HemoBand Sterile HB-1M (Standard Length - 14")

Device Class : 2

Duns Number: 051632466

Premarket Exempt : No

Product Code : KOC

Prescription Use : Yes

Device Count : 1

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