FDA.reportPublic FDA data

Quality Choice

Primary DI
00635515958951
Brand
Quality Choice
Company
CHAIN DRUG MARKETING ASSOCIATION, INC.
Model
95895
Device description
Sterile Saline Wound Wash. Packaged in an Aerosol (BOV) can.
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10635515958958PackageGS148In Commercial Distribution
00635515958951PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063551595895810635515958958
00635515958951006355159589516355159589510635515958951

GMDN Terms#

Term, Definition table
TermDefinition
Wound irrigation sterile salineA sterile solution of sodium chloride (NaCl), sometimes with additional compounds, intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and is typically provided in an appropriate container. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature33 Degrees Fahrenheit120 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
(718)690-7099riyirhiaro@premier-brands.com
(718)878-3097amathew@premier-brands.com

Regulatory Flags#

DUNS number
011920774
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00635515998537Quality Choice6355159985372021-08-09
00635515947443QUALITY CHOICE89-352QC-947442017-02-15
00635515958920QUALITY CHOICE89-362QC-958922017-02-15
00635515986701QUALITY CHOICE89-375QC-986702017-02-15
00635515992207QUALITY CHOICE89-355QC-992202017-02-15
00635515986794QUALITY CHOICE89-50KQC-986792017-02-15
00635515900486Quality Choice One Step Pregnancy TestFPPL2016-07-21
00635515956643Quality Choice Early Result Pregnancy TestPLPL2016-07-21
00635515900493Quality Choice One Step Pregnancy TestFPPL2016-07-21
00635515970717Quality Choice Early Result Pregnancy TestPLPL2016-07-21
00635515959347Quality Choice AutoletAT 0274QC2023-02-03
00761059276333Quality Choice AutoletAT 0274QC2023-02-03
00635515959354Quality Choice UniletAT 0575QC2023-01-26
00635515959361Quality Choice UniletAT 0565QC2023-01-26
00635515994775Quality Choice UniletAT 0585QC2023-01-26
00635515966130Quality ChoiceQC-96613QC-966132022-06-16
10635515966137Quality ChoiceQC-96613QC-966132022-06-16
00635515958838Quality choice TamponsBQCGR202016-09-20
00635515958845Quality choice TamponsBQCGS182016-09-20
00635515958852Quality choice TamponsBQCGP182016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144635CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08
00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990178Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990260Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990352Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990444Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990536Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990628Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990710Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990802Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990895Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
10884389161562MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-06
00361470000175Amerigel Saline Wound WashAmerx Health Care Corp.FRO2026-06-22
00050428280669CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
00050428453599CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
50192253067901ASOCardinal Health 200, LLCFRO2026-06-03