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

EVACUATOR, BLADDER, MANUALLY OPERATED (FFD) (5) Enteral Syringes with enteral specific connectors (PNR) (3) DISPENSER, LIQUID MEDICATION (KYX) (2)

Premarket Exempt

No Yes

Clear

CareTip - 05060460848340 Catalog Number : OBA-D

Device Description : CareTip, Oral, Bottle Adaptor, Single Use 24mm – 28mm

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

Enteral - 05060590880791 Catalog Number : DBP-250

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

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : FFD

Prescription Use : No

Device Count : 1

Enteral - 05060590880821 Catalog Number : DBP-500

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

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : FFD

Prescription Use : No

Device Count : 1

Enteral - 05060590880852 Catalog Number : DBP-1000

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

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : FFD

Prescription Use : No

Device Count : 1

Enteral - 05060590880883 Catalog Number : DBP-1500

Device Description : Enteral, Drainage Bag, PVC, Single Use 1500ml

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : FFD

Prescription Use : No

Device Count : 1

Enteral - 05060590880913 Catalog Number : DBP-2000

Device Description : Enteral, Drainage Bag, PVC, Single Use 2000ml

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : FFD

Prescription Use : No

Device Count : 1

CareTip - 05060590881255 Catalog Number : OS-20

Device Description : CareTip, Oral, Syringe, Single Use 20ml

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

Enteral - 05060590883372 Catalog Number : ELDISO-PFC-1

Device Description : Enteral, Syringe, ISOSAF™ and Push Fit Cap, Single Use 1ml Low Dose Tip

Device Class :

Duns Number: 216643186

Premarket Exempt : No

Product Code : PNR

Prescription Use : No

Device Count : 1

Enteral - 05060590883402 Catalog Number : ELDISO-PFC-3

Device Description : Enteral, Syringe, ISOSAF™ and Push Fit Cap, Single Use 3ml Low Dose Tip

Device Class :

Duns Number: 216643186

Premarket Exempt : No

Product Code : PNR

Prescription Use : No

Device Count : 1

Enteral - 05060590883433 Catalog Number : ELDISO-PFC-6

Device Description : Enteral, Syringe, ISOSAF™ and Push Fit Cap, Single Use 6ml Low Dose Tip

Device Class :

Duns Number: 216643186

Premarket Exempt : No

Product Code : PNR

Prescription Use : No

Device Count : 1

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