Smarthealth, Inc.

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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

System, Delivery, Allergen And Vaccine (LDH) (8) Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (LXG) (1) Tape And Bandage, Adhesive (KGX) (1)

Premarket Exempt

No Yes

Clear

SmartPractice - 00854498007054 Catalog Number : AL1701M

Device Description : patchProtect, 100 sheets, Medium

Device Class :

Duns Number: 061081477

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 100

SmartPractice - 00854498007085 Catalog Number : ALA1711

Device Description : patchTransport, 50 trays

Device Class :

Duns Number: 061081477

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 50

SmartPractice - 00854498007108 Catalog Number : AL71200

Device Description : allergEAZE Patch Test Chambers, non-woven, 100X10

Device Class : U

Duns Number: 061081477

Premarket Exempt : No

Product Code : LDH

Prescription Use : Yes

Device Count : 100

SmartPractice - 00854498007115 Catalog Number : AL71300

Device Description : allergEAZE Clear Patch Test Chambers, 100X10

Device Class : U

Duns Number: 061081477

Premarket Exempt : No

Product Code : LDH

Prescription Use : Yes

Device Count : 100

SmartPractice - 00854498007146 Catalog Number : AL7005

Device Description : Finn Chambers on Scanpor OPEN 8mm, 50x10, 50/box

Device Class : U

Duns Number: 061081477

Premarket Exempt : No

Product Code : LDH

Prescription Use : Yes

Device Count : 50

SmartPractice - 00854498007153 Catalog Number : AL7001

Device Description : Finn Chambers on Scanpor 8mm, 100x10, 100/box

Device Class : U

Duns Number: 061081477

Premarket Exempt : No

Product Code : LDH

Prescription Use : Yes

Device Count : 100

SmartPractice - 00854498007160 Catalog Number : AL7001PP

Device Description : Finn Chambers on Scanpor 8mm PP, 100x10, 100/box

Device Class : U

Duns Number: 061081477

Premarket Exempt : No

Product Code : LDH

Prescription Use : Yes

Device Count : 100

SmartPractice - 00854498007177 Catalog Number : AL7002

Device Description : Finn Chambers on Scanpor 8mm, 50x5 AL, 50/box

Device Class : U

Duns Number: 061081477

Premarket Exempt : No

Product Code : LDH

Prescription Use : Yes

Device Count : 50

SmartPractice - 00854498007191 Catalog Number : AL7000

Device Description : Finn Chambers on Scanpor 8mm, 25x10, 25/box

Device Class : U

Duns Number: 061081477

Premarket Exempt : No

Product Code : LDH

Prescription Use : Yes

Device Count : 25

SmartPractice - 00854498007221 Catalog Number : AL7003PP

Device Description : Finn Chambers on Scanpor 8mm PP, 150x1, 150/box

Device Class : U

Duns Number: 061081477

Premarket Exempt : No

Product Code : LDH

Prescription Use : Yes

Device Count : 150

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