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

DISPENSER, LIQUID MEDICATION (KYX) (5) EVACUATOR, BLADDER, MANUALLY OPERATED (FFD) (2) PROTECTOR, OSTOMY (EXE) (2) SYRINGE, IRRIGATING (NON DENTAL) (KYZ) (1)

Premarket Exempt

No Yes

Clear

Enteral - 05060460843970 Catalog Number : EN-PLUG-S

Device Description : Enteral, Stoma Plug, ENPLUG, Single Patient Use 10, 12, 14, 16Fr x 4cm

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : EXE

Prescription Use : No

Device Count : 1

Enteral - 05060460843994 Catalog Number : EN-PLUG-XL

Device Description : Enteral, Stoma Plug, ENPLUG, Single Patient Use 18, 20Fr x 7cm

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : EXE

Prescription Use : No

Device Count : 1

Enteral - 05060460845554 Catalog Number : BAISO1

Device Description : Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 1 – 12-15mm

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

Enteral - 05060460845585 Catalog Number : BAISO2

Device Description : Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 2 – 14 – 16.5mm

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

Enteral - 05060460845615 Catalog Number : BAISO3

Device Description : Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 3 – 17 – 20.5mm

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

Enteral - 05060460845646 Catalog Number : BAISO4

Device Description : Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 4 – 24 – 26mm

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

Enteral - 05060460845677 Catalog Number : CT60

Device Description : Enteral, Syringe, CareTip Catheter Tip, Single Use 60ml

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYZ

Prescription Use : No

Device Count : 1

Enteral - 05060460845707 Catalog Number : DBISO-100

Device Description : Enteral, Drainage Bag, EVA, Single Use 100ml

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : FFD

Prescription Use : No

Device Count : 1

CareTip - 05060460845790 Catalog Number : OS-10

Device Description : CareTip, Oral, Syringe, Single Use 10ml

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

Enteral - 05060460848043 Catalog Number : DBISON-500

Device Description : Enteral, Drainage Bag, EVA, Single Use Without Clamp, 500ml

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : FFD

Prescription Use : No

Device Count : 1

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