FDA.reportPublic FDA data

QMS - 42CFHY

Primary DI
00850014947156
Brand
QMS - 42CFHY
Company
QUALITY MEDICAL SUPPLY, INC.
Model
01
Device description
42" CUFFED, HYDROCARE DISPOSABLE KIT
Published
2019-12-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00850014947156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014947156008500149471568500149471560850014947156

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.

Contacts#

Phone, Email table
PhoneEmail
6236404646JULIE@QMSAZ.COM

Regulatory Flags#

DUNS number
969138283
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014947002QMS - 48SBST011482019-12-12
00850014947019QMS - 48CFST011502019-12-12
00850014947026QMS - 48SBSP01SP1482019-12-12
00850014947033QMS - 48CFSP012019-12-12
00850014947040QMS - 48SBOP012019-12-12
00850014947057QMS - 48CFOP012019-12-12
00850014947064QMS - 48SBHY012019-12-12
00850014947071QMS - 48CFHY012019-12-12
00850014947088QMS - 42SBST012019-12-12
00850014947095QMS - 42CFST012019-12-12
00850014947101QMS - 42SBSP012019-12-12
00850014947118QMS - 42CFSP012019-12-12
00850014947125QMS - 42SBOP012019-12-12
00850014947132QMS - 42CFOP012019-12-12
00850014947149QMS - 42SBHY012019-12-12
00850014947163QMS - AQUA CLEANSE012019-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD917665100Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665110Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665120Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665700Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665920Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665930Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
00190776433352MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433369MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433376MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433383MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433390MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433406MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433413MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433420MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433437MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433444MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433451MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433468MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433475MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433482MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433499MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433505MillenniumAvalign Technologies, Inc.FFQ2026-10-05
G141554100200Carnegie Surgical LLCCarnegie Surgical LLCFFQ2026-09-30
00190776432362MillenniumAvalign Technologies, Inc.FFQ2026-09-24
00860015748508Thermora AnoscopeOMEC Medical (NV) Inc.FFQ2026-07-31
00190776422189MillenniumAvalign Technologies, Inc.FFQ2026-07-28
00850048720619Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720626Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720633Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720640Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23