Gastroklenz 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, Peritoneal, Automatic Delivery (FKX) (4)

Premarket Exempt

Clear

CloudCath Drain Set - Baxter Configuration - 00860006810207 Catalog Number :

Device Description : Drain Set Finished Sterile, Baxter Compatible

Device Class :

Duns Number: 081043696

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

CloudCath Connect - Patient Monitoring Software - 00860006810238 Catalog Number :

Device Description : Patient Monitoring Software/System

Device Class : 2

Duns Number: 081043696

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

CloudCath Drain Set - Fresenius Configuration - 00860006810245 Catalog Number :

Device Description : Drain Set Finished Sterile, Fresenius Compatible

Device Class : 2

Duns Number: 081043696

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

CloudCath Sensor (Sensing Hardware) - 00860006810283 Catalog Number :

Device Description : Sensing Hardware

Device Class : 2

Duns Number: 081043696

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

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