FDA.reportPublic FDA data

BD

Primary DI
50885403530294
Brand
BD
Company
BECTON, DICKINSON AND COMPANY
Model
140068-01
Catalog number
140068-01
Device description
STERILE WATER IRRIGATION BOTTLE 1000 ML
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083042000WOUND FLUSH, STERILE WATER & NORMAL SALINENurse Assist, Inc.2008-12-18FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403530294PrimaryGS10
10885403530296Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540353029450885403530294
1088540353029610885403530296

GMDN Terms#

Term, Definition table
TermDefinition
Wound irrigation sterile waterA fluid consisting of sterile water (no other compounds/additives) 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 typically provided in an appropriate container. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1000Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature060 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(844)823-5433ProductInquiry@bd.com

Regulatory Flags#

DUNS number
001292192
Device count
9
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30382903678717BD Vacutainer® Sodium HeparinN (NH) 75 USP Units Blood Collection Tubes3678713678712016-07-28
50885403530225BD140061-01140061-012026-05-13
50885403530232BD140063-01140063-012026-05-13
50885403530249BD140062-01140062-012026-05-13
50885403530256BD140064-01140064-012026-05-13
50885403530263BD140065-01140065-012026-05-13
50885403530270BD140066-01140066-012026-05-13
50885403530287BD140067-01140067-012026-05-13
30382903678786BD Vacutainer® Sodium HeparinN (NH) 95 USP Units Blood Collection Tubes3678783678782016-07-28
30382903679639BD Vacutainer® PST™ Lithium HeparinN (LH) Blood Collection Tubes3679633679632016-07-28
30382903679608BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units3679603679602016-07-28
30382903679615BD Vacutainer® PST™ Gel and Lithium HeparinN 65 Units3679613679612016-07-28
30382903679622BD Vacutainer® PST™ Gel and Lithium HeparinN 83 Units3679623679622016-07-28
30382903678748BD Vacutainer® Sodium HeparinN (NH) 158 USP Units Blood Collection Tubes3678743678742016-07-28
00382904422882BD BACTEC™ Myco/F Lytic Culture Vials4422884422882025-02-07
30382903672906BD Vacutainer® Multiple Sample Luer Adapter3672903672902016-12-12
30382903679875BD Vacutainer® SST™3679873679872016-07-28
30382903672876BD Vacutainer® Safety-Lok™ Blood Collection Set3672873672872016-07-28
30382903672920BD Vacutainer® Safety-Lok™ Blood Collection Set3672923672922016-07-28
30382903672944BD Vacutainer® Safety-Lok™ Blood Collection Set3672943672942016-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
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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
09120073781550GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781574GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169443MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169467MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169474MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169481MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169498MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169504MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344170197MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-10-13
10192253046274KendallCardinal Health 200, LLCFRO2025-09-22
10192253047837XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047844XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047851XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047868XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047806XeroformCardinal Health 200, LLCFRO2025-09-10
10192253046311KendallCardinal Health 200, LLCFRO2025-09-09
10192253046373KendallCardinal Health 200, LLCFRO2025-09-09
10192253046472KendallCardinal Health 200, LLCFRO2025-09-09
10192253046540KendallCardinal Health 200, LLCFRO2025-09-09