DirectMed, Inc.

GUDID 10850038863163

Extension Set with 0.2um filter

Directmed, Inc.

Intravenous administration tubing extension set
Primary Device ID10850038863163
NIH Device Record Key1c895626-24d0-4a7a-a50a-fbe21706efb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirectMed, Inc.
Version Model NumberSM-007
Company DUNS969484237
Company NameDirectmed, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS110850038863163 [Primary]

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-13
Device Publish Date2024-05-03

On-Brand Devices [DirectMed, Inc. ]

10850038863118EXTENSION SET 7" SMALLBORE
10850038863101EXTENSION SET 7” SMALLBORE BONDED VALVE
00850038863111EXTENSION SET 7" SMALLBORE
00850038863104EXTENSION SET 7” SMALLBORE BONDED VALVE
10850038863163Extension Set with 0.2um filter
00850038863166Extension Set with 0.2um filter
10850038863170Administration Set-Female Luer lock, 150µm Filter w/Male Luer Lock, Sterile
00850038863173Administration Set-Female Luer lock, 150µm Filter w/Male Luer Lock, Sterile

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.