Kew Medical

GUDID 10816415020192

112" UltraSpec IV Administration Set, 15 Micron Screen, Back Check Valve, Needleless Connectors(3), Male Luer Lock (2.8 m) Length - Box

DOUGLAS MEDICAL PRODUCTS, INC.

Intravenous administration set
Primary Device ID10816415020192
NIH Device Record Keyc7321a24-ca06-49aa-a491-a7853d2a99d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameKew Medical
Version Model NumberQAU5131
Company DUNS121040922
Company NameDOUGLAS MEDICAL PRODUCTS, INC.
Device Count50
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 Datefalse
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
GS100816415020195 [Unit of Use]
GS110816415020192 [Primary]

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 Date2017-09-15

On-Brand Devices [Kew Medical]

1081641502025311" IV Administration Set, Dual-Spike Adapter, 15 Micron Screen, Spike Port Adapter (0.3 m) Leng
10816415020215112" UltraSpec IV Administration Set, Back Check Valve, Needleless Connectors(2), 0.22 Micron Fi
10816415020208106" UltraSpec IV Administration Set, 1.2 Micron Filter, Needleless Connector, Male Luer Lock (2
10816415020192112" UltraSpec IV Administration Set, 15 Micron Screen, Back Check Valve, Needleless Connectors(
10816415020185106" UltraSpec IV Administration Set, 0.22 Micron Filter, Needleless Connector, Male Luer Lock (
10816415020178112" UltraSpec IV Administration Set, 15 Micron Screen, Needleless Connectors(2), Back Check Val
10816415020161106" UltraSpec IV Administration Set, 15 Micron Screen, Needleless Connector, Male Luer Lock (2.
10816415020154100" UltraSpec IV Administration Set, 15 Micron Screen, Male Luer Lock (2.5 m) Length - Box
10816415020055106" IV Administration Set, 15 Micron Screen, Needleless Connector, Male Luer Lock (2.7 m) Lengt
10816415020048112" IV Administration Set, 15 Micron Screen, Back Check Valve, Needleless Connectors(2), Male L
10816415020031100" IV Administration Set, 15 Micron Screen, Male Luer Lock (2.5 m) Length - Box

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.