QMS - AQUA CLEANSE

GUDID 00850014947163

AQUA CLEANSE COLON IRRIGATION DEVICE

QUALITY MEDICAL SUPPLY, INC.

Colonic lavage unit
Primary Device ID00850014947163
NIH Device Record Key31237189-2ef5-4428-9913-d6f980930951
Commercial Distribution StatusIn Commercial Distribution
Brand NameQMS - AQUA CLEANSE
Version Model Number01
Company DUNS969138283
Company NameQUALITY MEDICAL SUPPLY, 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6236404646
EmailJULIE@QMSAZ.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100850014947163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPLColonic Irrigation System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-20
Device Publish Date2019-12-12

Devices Manufactured by QUALITY MEDICAL SUPPLY, INC.

00850014947002 - QMS - 48SBST2019-12-20 48" SMOOTH-BOR, SMOOTH-TIP DISPOSABLE KIT
00850014947019 - QMS - 48CFST2019-12-20
00850014947026 - QMS - 48SBSP2019-12-20 48" SMOOTH-BOR, SMOOTH-PETITE DISPOSABLE KIT
00850014947033 - QMS - 48CFSP2019-12-20 48" CUFFED, SMOOTH-PETITE DISPOSABLE KIT
00850014947040 - QMS - 48SBOP2019-12-20 48" SMOOTH-BOR, ONE-PIECE DISPOSABLE KIT
00850014947057 - QMS - 48CFOP2019-12-20 48" CUFFED, ONE-PIECE DISPOSABLE KIT
00850014947064 - QMS - 48SBHY2019-12-20 48" SMOOTH-BOR, HYDROCARE DISPOSABLE KIT
00850014947071 - QMS - 48CFHY2019-12-20 48" CUFFED, HYDROCARE DISPOSABLE KIT

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