FDA.reportPublic FDA data

Care One

Primary DI
10341520310109
Brand
Care One
Company
Ahold U.S.A., Inc.
Model
532164
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
Rx
false
OTC
true
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10341520310109PackageGS148In Commercial Distribution
00341520310102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1034152031010910341520310109
00341520310102003415203101023415203101020341520310102

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
170199058
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00041520078438CareOne0415200784382019-08-30
00041520010704CareOne0415200107042019-06-28
00041520013965CareOne0415200139652020-09-27
00041520014009CareOne0415200140092019-06-28
00041520019714CareOne0415200197142019-06-28
00041520089298CareOne0415200892982019-07-31
00041520089304CareOne0415200893042019-06-28
00041520096777CareOne0415200967772019-07-31
00041520096784CareOne0415200967842019-07-31
00041520096791CareOne0415200967912019-06-28
00041520096821CareOne0415200968212019-06-28
00041520125033CareOne0415201250332019-07-31
00041520875754CareOne0415208757542019-06-28
00041520877710CareOne0415208777102019-06-28
00041520877727CareOne0415208777272019-06-28
00041520880963CareOne0415208809632019-06-28
00341520317170CareOne3415203171702020-09-27
00341520877889CareOne3415208778892019-07-31
00041520171283Care OneDigital Pregnancy Test2021-04-22
00041520171269Care OneOne Step Pregnancy Test2021-04-22

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Primary DI, Brand, Company table
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01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4Sion Brands LLCFRO2026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4Sion Brands LLCFRO2026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz TubeSion Brands LLCFRO2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz TubeSion Brands LLCFRO2026-06-01
00850087488259CeeportCEEPORT INC.FRO2026-05-29
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10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
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10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
00850087488006CeeportCEEPORT INC.FRO2026-05-22
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
00324357020451Zeni MedicalFocus Health Group, Inc.FRO2026-04-13
00324357020680Zeni MedicalFocus Health Group, Inc.FRO2026-04-13
00324357060440Zeni MedicalFocus Health Group, Inc.FRO2026-04-13
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10