Precision Delivery IV Extension Set

GUDID 20634624621040

QUEST MEDICAL INC

Intravenous administration tubing extension set
Primary Device ID20634624621040
NIH Device Record Keycfb0a261-8688-4bf7-8d9f-4747c29e2309
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision Delivery IV Extension Set
Version Model NumberPDM60F
Company DUNS041810693
Company NameQUEST MEDICAL 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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100634624621046 [Primary]
GS120634624621040 [Package]
Contains: 00634624621046
Package: [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-02-15
Device Publish Date2021-02-05

On-Brand Devices [Precision Delivery IV Extension Set]

20634624621101PDV60F
20634624621095PDV60
20634624621088PDV06F
20634624621071PDV06
20634624621064PDMV60F
20634624621057PDMV60
20634624621040PDM60F
20634624621033PDM60
20634624621026PD60F
20634624621019PD60
20634624911066PD06F

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