GERI-GENTLE CORPORATION

GERI-GENTLE CORPORATION

Address:5 Hollywood Ct,South Plainfield,NJ,07080,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

Catheter, Retention Type, Balloon (EZL) (8) Set, Administration, Intravascular (FPA) (1) Syringe, Antistick (MEG) (1)

Premarket Exempt

No Yes

Clear

IV Administration Set - 00369771000214 Catalog Number :

Device Description : IV Administration Set

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Syringes Safety - 00369771000832 Catalog Number :

Device Description : SYR U100 1cc 29x.5

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : MEG

Prescription Use : No

Device Count : 1

Foley Catheter - 00369771001006 Catalog Number :

Device Description : Foley Catheter 14fr 30cc

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

Foley Catheter - 00369771001013 Catalog Number :

Device Description : Foley Catheter 14fr 5cc

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

Foley Catheter - 00369771001037 Catalog Number :

Device Description : Foley Catheter 16fr 5cc

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

Foley Catheter - 00369771001044 Catalog Number :

Device Description : Foley Catheter 18fr 5cc

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

Foley Catheter - 00369771001051 Catalog Number :

Device Description : Foley Catheter 18fr 30cc

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

Foley Catheter - 00369771001068 Catalog Number :

Device Description : Foley Catheter 20fr 30cc

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

Foley Catheter - 00369771001075 Catalog Number :

Device Description : Foley Catheter 20fr 5cc

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

Foley Catheter - 00369771001082 Catalog Number :

Device Description : Foley Catheter 22fr 30cc

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

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