bFed™ SK-2001

GUDID 00867622000449

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

U DELIVER MEDICAL L.L.C.

Enteral feeding kit, adult/paediatric, non-sterile
Primary Device ID00867622000449
NIH Device Record Key7e43564b-5527-4b78-9dac-18c1260cf6a6
Commercial Distribution StatusIn Commercial Distribution
Brand NamebFed™
Version Model NumberSK-2001
Catalog NumberSK-2001
Company DUNS080494259
Company NameU DELIVER MEDICAL L.L.C.
Device Count7
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9522000270
Emailinfo@udelivermedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100867622000449 [Primary]
GS100867622000463 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PIFGastrointestinal Tubes With Enteral Specific Connectors

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2018-02-02

On-Brand Devices [bFed™]

00867622000456bFed Refill kit containing 10 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (
00867622000449bFed Starter kit containing 5 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (

Trademark Results [bFed]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BFED
BFED
88649828 not registered Live/Pending
U Deliver Medical
2019-10-10

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