FDA.reportPublic FDA data

MEDLINE

Primary DI
10197344111534
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
BOM51300NSBX
Catalog number
BOM51300NSBX
Device description
TOTAL SECURE LARGE NON-STERILE
Published
2026-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYJHOLDER, URETERAL CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYJHolder, Ureteral CatheterGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344111531PackageGS130In Commercial Distribution
10197344111534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734411153120197344111531
1019734411153410197344111534

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sequencing reagent kit IVDA collection of reagents and other associated materials intended to be used on-board a nucleic acid sequencing instrument for the genetic analysis of a clinical specimen. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) and deoxynucleotides (dNTPs). It does not contain analyte-specific reagents and is not intended to be used for whole genome or complementary deoxyribonucleic acid (cDNA) library construction.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344039791MEDLINEHNX22075HNX220752024-10-11
10197344039807MEDLINEHNX22100HNX221002024-10-11
10888277348226MEDLINEMDS630S2MDS630S22026-07-29
10888277699472MEDLINEDYND300010SDYND300010S2026-07-29
10888277699489MEDLINEDYND300015SDYND300015S2026-07-29
10888277699496MEDLINEDYND300020SDYND300020S2026-07-29
10888277699502MEDLINEDYND300025SDYND300025S2026-07-29
10888277699533MEDLINEDYND300050SDYND300050S2026-07-29
10888277701588MEDLINEMSC9912EPMSC9912EP2025-09-24
10888277701595MEDLINEMSC9918EPMSC9918EP2025-09-24
10888277701618MEDLINEMSC9945EPMSC9945EP2025-09-24
10888277701625MEDLINEMSC9948EPMSC9948EP2025-09-24
10888277701632MEDLINEMSC9966EPMSC9966EP2025-09-24
10888277701649MEDLINEMSC99812EPMSC99812EP2025-09-24
30193489103964MEDLINE1202YLW3AOS2026-07-28
30193489103971MEDLINE1202YLW3XL2026-07-28
10197344216123MEDLINESSBCS21GLSSBCS21GL2026-07-24
10197344219575MEDLINEMDS99905MDS999052026-07-24
10653160391326MEDLINEEBSI1865EBSI18652026-07-24
30193489017742MEDLINE6651CBL22X16651CBL22X12026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874957346Create BiotechCREATE BIOTECH CO., LTD.EYJ2026-07-21
10197344157174MEDLINEMEDLINE INDUSTRIES, INC.EYJ2026-07-17
10197344111527MEDLINEMEDLINE INDUSTRIES, INC.EYJ2026-06-25
10192253071054MC JohnsonCardinal Health 200, LLCEYJ2026-05-20
10192253071153MC JohnsonCardinal Health 200, LLCEYJ2026-05-20
10885380211256MC JohnsonCardinal Health 200, LLCEYJ2026-05-20
00850067913009TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
00850067913016TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
10850067913006TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
10850067913013TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
00612479280687McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281189McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281202McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281226McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281196McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479280717McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281219McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281233McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
05430004283522FlexGRIPBedalEYJ2025-12-03
05430004283782FlexGRIPBedalEYJ2025-12-03
05430004283539FlexGRIPBedalEYJ2025-12-03
05430004283799FlexGRIPBedalEYJ2025-12-03
05430003674284FlexGRIPBedalEYJ2025-12-01
05430003674291FlexGRIPBedalEYJ2025-12-01
06009900639604Another HandWISMED PL SP Z O OEYJ2025-03-17
00850058254333TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
00850058254364TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
00850058254371TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10850058254330TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10850058254361TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03