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) (9) Enteral Syringes with enteral specific connectors (PNR) (1)

Premarket Exempt

No Yes

Clear

Enteral - 05060460848074 Catalog Number : BAISO35

Device Description : Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 3.5 – 19 – 23mm

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

Enteral - 05060460848104 Catalog Number : BAISO1-S

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 - 05060460848135 Catalog Number : BAISO2-S

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

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

Enteral - 05060460848166 Catalog Number : BAISO3-S

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 - 05060460848197 Catalog Number : BAISO35-S

Device Description : Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 3.5 – 19 – 23mm

Device Class :

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

Enteral - 05060460848227 Catalog Number : BAISO4-S

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 - 05060460848258 Catalog Number : ECISO-10

Device Description : Enteral, Syringe Accessories, ENFit® Male Syringe Cap, Single Use 10/blister

Device Class :

Duns Number: 216643186

Premarket Exempt : No

Product Code : PNR

Prescription Use : No

Device Count : 1

CareTip - 05060460848289 Catalog Number : OBA-A

Device Description : CareTip, Oral, Bottle Adaptor, Single Use 12mm – 16mm

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

CareTip - 05060460848302 Catalog Number : OBA-B

Device Description : CareTip, Oral, Bottle Adaptor, Single Use 17mm – 20mm

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

CareTip - 05060460848326 Catalog Number : OBA-C

Device Description : CareTip, Oral, Bottle Adaptor, Single Use 21mm – 23mm

Device Class : 1

Duns Number: 216643186

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

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