FDA.reportPublic FDA data

MEDLINE

Primary DI
20197344020789
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYND364958
Catalog number
DYND364958
Device description
TUBE,VAC,URINE,BORIC ACID,4ML,13X75,
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSMCULTURE MEDIA, NON-PROPAGATING TRANSPORT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSMCulture Media, Non-Propagating TransportMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220739000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220739000Disposable Urine Collection TubeZhejiang Gongdong Medical Technology Co., Ltd.2022-11-17JSM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30197344020786PackageGS110In Commercial Distribution
20197344020789PrimaryGS10
10197344020782Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3019734402078630197344020786
2019734402078920197344020789
1019734402078210197344020782

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry; Keep away from sunlight; Protect from freezing, Avoid excessive heat

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344227464MEDLINEDYNCCDS10TDYNCCDS10T2026-11-05
00197344154336MEDLINENON25511NON255112026-11-03
10197344220588MEDLINEMSC608ASGVMSC608ASGV2026-11-03
10198459763977MEDLINEURO195714URO1957142026-09-15
10198459809224MEDLINEVASC2005VASC20052026-11-03
10198459814969MEDLINEVASC2008VASC20082026-11-03
10198459815508MEDLINEVASC1794CVASC1794C2026-11-03
10653160394471MEDLINEDYNDV2774ADYNDV2774A2026-11-04
20888277636757MEDLINEMDTZ1068516AWMDTZ1068516AW2026-11-03
20080196921277GeminiGEM2140GEM21402016-10-14
10197344148462MEDLINERTDCIHCMGRTDCIHCMG2026-10-30
10197344148479MEDLINERTDCIHCMNRTDCIHCMN2026-10-30
10197344148486MEDLINERTDCIHCMPRTDCIHCMP2026-10-30
10197344148493MEDLINERTDCIHCMRRTDCIHCMR2026-10-30
10197344148509MEDLINERTDCIHCMYRTDCIHCMY2026-10-30
10197344148516MEDLINERTDCIHCMZRTDCIHCMZ2026-10-30
10197344148523MEDLINERTDCINCMBRTDCINCMB2026-10-30
10197344148530MEDLINERTDCINCMGRTDCINCMG2026-10-30
10197344148547MEDLINERTDCINCMNRTDCINCMN2026-10-30
10197344148554MEDLINERTDCINCMPRTDCINCMP2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344020779MEDLINEMEDLINE INDUSTRIES, INC.JSM2026-08-19
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16973471962171BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
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16973471962195BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962201BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962218BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
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16973471962232BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962249BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962256BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962263BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
38053326011826BD FCTCOPAN ITALIA SPAJSM2026-01-26
38053326009557Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326009861Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
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38053326011079Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011185Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
58053326010403Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011710UriSponge™COPAN ITALIA SPAJSM2025-03-12
38053326011598UTM®COPAN ITALIA SPAJSM2024-11-13
38053326011604UTM® COPAN ITALIA SPAJSM2024-11-13
38053326011611UTM® COPAN ITALIA SPAJSM2024-11-13
16977644780029BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780036BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780043BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780012BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-12
16973471969941BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-07-23
16973471969996BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-07-23