FDA.reportPublic FDA data

MEDLINE

Primary DI
10197344132928
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
BCLLADCC
Catalog number
BCLLADCC
Device description
BLOOD CULTURE, LUER LOCK ACCESS DEVICE
Published
2026-01-23
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
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200027000Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample AdapterJiangsu Caina Medical Co.,Ltd2020-09-09JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344132925PackageGS160In Commercial Distribution
30197344132922PackageGS14In Commercial Distribution
10197344132928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734413292520197344132925
3019734413292230197344132922
1019734413292810197344132928

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection tube holder/needleA sterile, hand-held cylindrical device with a pre-attached needle designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry; Keep away from sunlight

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489135909MEDLINEDYNJP2228SGDYNJP2228SG2026-07-17
10197344112722MEDLINESSBCS23GTSSBCS23GT2026-07-17
10197344157174MEDLINESNAPSECUREPSNAPSECUREP2026-07-17
10197344169450MEDLINEMSCSRG9736MSCSRG97362026-07-17
10197344205141MEDLINEMSC608ASXLMSC608ASXL2026-07-17
10197344216116MEDLINESSBCS21GSSBCS21G2026-07-17
10197344216130MEDLINESSBCS21GTSSBCS21GT2026-07-17
10197344216147MEDLINESSBCS23GSSBCS23G2026-07-17
10197344216154MEDLINESSBCS23GLSSBCS23GL2026-07-17
10197344216161MEDLINESSBCS25GSSBCS25G2026-07-17
10197344216178MEDLINESSBCS25GLSSBCS25GL2026-07-17
10197344216185MEDLINESSBCS25GTSSBCS25GT2026-07-17
10884389362020MEDLINEDYNJSMD01DYNJSMD012026-07-17
10888277407954MEDLINEOR87VOR87V2026-07-17
20193489029939MEDLINEMDTZ1020872GHMDTZ1020872GH2026-07-17
20193489029953MEDLINEMDTZ1020872GJMDTZ1020872GJ2026-07-17
20197344033925MEDLINEMLABDISH35MLABDISH352026-07-17
20197344033956MEDLINEMLABDISH65MLABDISH652026-07-17
20197344219428MEDLINEMDT2168054XGVMDT2168054XGV2026-07-17
20197344219442MEDLINEMDT2168104GVMDT2168104GV2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344112722MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216116MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216130MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216147MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216154MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216161MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216178MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216185MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
00850048720343C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720466C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720558C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720237C-QuestLifeOutcomes LLCJKA2026-07-09
50192253051153CARDINAL HEALTHCardinal Health 200, LLCJKA2026-06-25
00199536930506BluelineTransparent Supply Solutions Ltd.JKA2026-06-05
00199536930513BluelineTransparent Supply Solutions Ltd.JKA2026-06-05
08887629000008BUHNSP TECH PTE LTDJKA2026-05-29
08887629000053BUCANSP TECH PTE LTDJKA2026-05-29
08887629000060BTANSP TECH PTE LTDJKA2026-05-29
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
10197344019649MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-23
10197344039715MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-17