Single Lead High Volume Pump Chamber

GUDID 10810080610481

MPS Pharma & Medical, Inc.

Compounding transfer set
Primary Device ID10810080610481
NIH Device Record Keyb9aac6a4-a6d4-4ede-b803-d6ac52eb13cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Lead High Volume Pump Chamber
Version Model Number1 PHARM-6
Company DUNS117970217
Company NameMPS Pharma & Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810080610484 [Primary]
GS110810080610481 [Package]
Contains: 00810080610484
Package: Case [50 Units]
In Commercial Distribution

FDA Product Code

NEPSystem/Device, Pharmacy Compounding

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-01
Device Publish Date2022-08-24

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