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) (4) EVACUATOR, BLADDER, MANUALLY OPERATED (FFD) (4) Enteral Syringes with enteral specific connectors (PNR) (1) PROTECTOR, OSTOMY (EXE) (1)

Premarket Exempt

No Yes

Clear

Enteral - 00850801006967 Catalog Number : VED-670

Device Description : Enteral, Drawing Up Device, Medicine Straw, Single Use 50mm

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

CareTip - 05060460843413 Catalog Number : OS-1

Device Description : CareTip, Oral, Syringe, Single Use 1ml

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

CareTip - 05060460843444 Catalog Number : OS-2

Device Description : CareTip, Oral, Syringe, Single Use 2.5ml

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

CareTip - 05060460843475 Catalog Number : OS-5

Device Description : CareTip, Oral, Syringe, Single Use 5ml

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

Enteral - 05060460843666 Catalog Number : DBISO-1000

Device Description : Enteral, Drainage Bag, EVA, Single Use 1000ml

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : FFD

Prescription Use : No

Device Count : 1

Enteral - 05060460843697 Catalog Number : DBISO-250

Device Description : Enteral, Drainage Bag, EVA, Single Use 250ml

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : FFD

Prescription Use : No

Device Count : 1

Enteral - 05060460843727 Catalog Number : DBISO-50

Device Description : Enteral, Drainage Bag, EVA, Single Use 50ml

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : FFD

Prescription Use : No

Device Count : 1

Enteral - 05060460843758 Catalog Number : DBISO-500

Device Description : Enteral, Drainage Bag, EVA, Single Use 500ml

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : FFD

Prescription Use : No

Device Count : 1

Enteral - 05060460843789 Catalog Number : ECISO

Device Description : Enteral, Syringe Accessories, ENFit® Male Syringe Cap, Single Use

Device Class :

Duns Number: 216643186

Premarket Exempt : No

Product Code : PNR

Prescription Use : No

Device Count : 1

Enteral - 05060460843956 Catalog Number : EN-PLUG-L

Device Description : Enteral, Stoma Plug, ENPLUG, Single Patient Use 10, 12, 14, 16Fr x 7cm

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : EXE

Prescription Use : No

Device Count : 1

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