GBUK ENTERAL LIMITED

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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

Enteral Syringes with enteral specific connectors (PNR) (4) EVACUATOR, BLADDER, MANUALLY OPERATED (FFD) (3) UTENSIL, EATING (ILC) (1)

Premarket Exempt

No Yes

Clear

Enteral - 05060590883464 Catalog Number : EISO-PFC-12

Device Description : Enteral, Syringe, ISOSAF™ and Push Fit Cap, Single Use 12ml

Device Class : 2

Duns Number: 216643186

Premarket Exempt : No

Product Code : PNR

Prescription Use : No

Device Count : 1

Enteral - 05060590883495 Catalog Number : EISO-PFC-20

Device Description : Enteral, Syringe, ISOSAF™ and Push Fit Cap, Single Use 20ml

Device Class :

Duns Number: 216643186

Premarket Exempt : No

Product Code : PNR

Prescription Use : No

Device Count : 1

Enteral - 05060590883525 Catalog Number : EISO-PFC-60

Device Description : Enteral, Syringe, ISOSAF™ and Push Fit Cap, Single Use 60ml

Device Class : 2

Duns Number: 216643186

Premarket Exempt : No

Product Code : PNR

Prescription Use : No

Device Count : 1

Enteral - 05060590883785 Catalog Number : EISO-PFC-35

Device Description : Enteral, Syringe, ISOSAF™ and Push Fit Cap, Single Use 35ml

Device Class :

Duns Number: 216643186

Premarket Exempt : No

Product Code : PNR

Prescription Use : No

Device Count : 1

Enteral - 05060590889008 Catalog Number : EMBTC-50

Device Description : Enteral Single Use Bottle Transfer Cap ISO 80369-3 ENFit

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : ILC

Prescription Use : No

Device Count : 1

Enteral - 05060590889374 Catalog Number : DBP-250HT

Device Description : Enteral ISOSAF Single Use Drainage Bag 250ml

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : FFD

Prescription Use : No

Device Count : 1

Enteral - 05060590889404 Catalog Number : DBP-500HT

Device Description : Enteral ISOSAF Single Use Drainage Bag 500ml

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : FFD

Prescription Use : No

Device Count : 1

Enteral - 05060590889435 Catalog Number : DBP-1000HT

Device Description : Enteral ISOSAF Single Use Drainage Bag 1000ml

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : FFD

Prescription Use : No

Device Count : 1

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