Extension Set

GUDID 20876604001705

Standard Bore Extension Set

Health Line International Corporation

Intravenous administration set
Primary Device ID20876604001705
NIH Device Record Key35be2b53-c1d9-4436-b38e-9f4bb7d1b18b
Commercial Distribution StatusIn Commercial Distribution
Brand NameExtension Set
Version Model NumberHLEV23554
Company DUNS806251398
Company NameHealth Line International Corporation
Device Count1
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100876604001701 [Primary]
GS110876604001708 [Package]
Contains: 00876604001701
Package: Inner Pack [50 Units]
In Commercial Distribution
GS120876604001705 [Package]
Contains: 10876604001708
Package: Case [4 Units]
In Commercial Distribution

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-11
Device Publish Date2017-03-15

On-Brand Devices [Extension Set]

20876604001705Standard Bore Extension Set
2087660400144610” Standard Bore Extension Set w/0.22 Micron Filter

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