U DELIVER MEDICAL L.L.C.

Address:7900 EXCELSIOR BLVD STE 108,Hopkins,MN,55343,US

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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

Gastrointestinal Tubes With Enteral Specific Connectors (PIF) (7)

Premarket Exempt

Clear

Bolink™ - 00860136002428 Catalog Number :

Device Description : Large Cap Gravity Feeding Set with Cross Spike and ENFit Connector

Device Class : 2

Duns Number: 080494259

Premarket Exempt : No

Product Code : PIF

Prescription Use : No

Device Count : 1

Bolink™ - 00860136002435 Catalog Number : BK-2085

Device Description : Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector

Device Class :

Duns Number: 080494259

Premarket Exempt : No

Product Code : PIF

Prescription Use : No

Device Count : 1

Bolink® - 00860136002466 Catalog Number :

Device Description : D Cap Gravity Feeding Set with ENFit Connector

Device Class :

Duns Number: 080494259

Premarket Exempt : No

Product Code : PIF

Prescription Use : No

Device Count : 1

Bolink(TM) - 00867622000401 Catalog Number : 1085

Device Description : Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector

Device Class :

Duns Number: 080494259

Premarket Exempt : No

Product Code : PIF

Prescription Use : Yes

Device Count : 1

Bolink(TM) - 00867622000418 Catalog Number : 1405

Device Description : Large Cap Gravity Feeding Set with ENFit Connector

Device Class :

Duns Number: 080494259

Premarket Exempt : No

Product Code : PIF

Prescription Use : Yes

Device Count : 1

bFed™ - 00867622000449 Catalog Number : SK-2001

Device Description : bFed Starter kit containing 5 Large Cap Bolink™ Gravity Feeding Sets with ENFit bFed Starter kit containing 5 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 2 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 3 375 mL Bolee™ Bags

Device Class :

Duns Number: 080494259

Premarket Exempt : No

Product Code : PIF

Prescription Use : Yes

Device Count : 7

bFed™ - 00867622000456 Catalog Number : SK-2002

Device Description : bFed Refill kit containing 10 Large Cap Bolink™ Gravity Feeding Sets with ENFit bFed Refill kit containing 10 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 4 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 7 375 mL Bolee™ Bags

Device Class :

Duns Number: 080494259

Premarket Exempt : No

Product Code : PIF

Prescription Use : Yes

Device Count : 40

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