FDA.reportPublic FDA data

QMS - 42SBHY

Primary DI
00850014947149
Brand
QMS - 42SBHY
Company
QUALITY MEDICAL SUPPLY, INC.
Model
01
Device description
"42"" SMOOTH-INTERIOR, HYDROCARE DISPOSABLE KIT"
Published
2019-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFQSpeculum, Rectal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFQSpeculum, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014947149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014947149008500149471498500149471490850014947149

GMDN Terms#

Term, Definition table
TermDefinition
Colonic lavage kit, non-surgicalA collection of non-sterile devices intended to be used with a colonic lavage system/unit for the administration of an irrigation solution (e.g., saline solution) via the rectum, for the non-surgical irrigation, cleansing, and evacuation of debris from the colon. It includes both an inflow tube (intended to facilitate the ingress of fluid into the colon) and a waste tube (intended to transport fluids and waste matter away from the patient), a colonic irrigation nozzle, and may include additional supportive devices (e.g., lubricant, connectors). The kit may also be intended to support enema delivery. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6236404646JULIE@QMSAZ.COM

Regulatory Flags#

DUNS number
969138283
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014947002QMS - 48SBST011482019-12-12
00850014947026QMS - 48SBSP01SP1482019-12-12
00850014947040QMS - 48SBOP012019-12-12
00850014947064QMS - 48SBHY012019-12-12
00850014947088QMS - 42SBST012019-12-12
00850014947101QMS - 42SBSP012019-12-12
00850014947125QMS - 42SBOP012019-12-12
00850014947019QMS - 48CFST011502019-12-12
00850014947033QMS - 48CFSP012019-12-12
00850014947057QMS - 48CFOP012019-12-12
00850014947071QMS - 48CFHY012019-12-12
00850014947095QMS - 42CFST012019-12-12
00850014947118QMS - 42CFSP012019-12-12
00850014947132QMS - 42CFOP012019-12-12
00850014947156QMS - 42CFHY012019-12-12
00850014947163QMS - AQUA CLEANSE012019-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055445961107SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961114SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961121SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961138SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961145SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961152SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961169SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961176SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961183SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961190SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961206SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961213SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961220SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961237SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961244SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961251SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961282SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961299SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961305SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961312SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961329SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961336SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961343SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961350SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961367SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961374SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961381SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961398SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961404SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961411SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12