Single lead High Volume Pump Chamber Set

GUDID 00816513022640

MPS MEDICAL, INC

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Primary Device ID00816513022640
NIH Device Record Key109d012c-69bc-4894-a473-c3bfe5f5f429
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle lead High Volume Pump Chamber Set
Version Model NumberG82711-M
Company DUNS079636164
Company NameMPS 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816513022640 [Primary]
GS110816513022647 [Package]
Package: BOX [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LHISet, I.V. Fluid Transfer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-25
Device Publish Date2017-02-22

On-Brand Devices [Single lead High Volume Pump Chamber Set]

00816513022657G82721-M
00816513022640G82711-M
10816513023569G827331-M
10816513023460G82721-MF

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