FDA.reportPublic FDA data

MEDLINE

Primary DI
10653160389507
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDH2199
Catalog number
DYNDH2199
Device description
BLOOD CULTURE KIT
Published
2025-08-24
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213481000Medline General Surgery TrayMedline Industries, Inc.2022-05-24LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160389500PackageGS150In Commercial Distribution
10653160389507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160389500006531603895006531603895000653160389500
1065316038950710653160389507

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, noninvasiveA collection of sterile, noninvasive devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes and a separate blood access device (e.g., intravenous catheter), for the routine collection of multiple blood specimens from a patient, for clinical analyses. It consists of various device combinations that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder; the set may connect to, but does not contain, an invasive blood access device(s) [e.g., an intravenous catheter]. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489069334NAMIC91400300914003002021-10-28
10193489069341NAMIC91400400914004002021-07-26
10193489077667NAMIC906324490190632449012022-02-23
10193489078039NAMICH74904490202H749044902022021-07-26
10193489111132MEDLINESTGWLR1865NTSTGWLR1865NT2021-07-18
10193489111149MEDLINESTGWLR3260NTSTGWLR3260NT2021-07-18
10193489111156MEDLINESTGWLR2135NTSTGWLR2135NT2021-07-18
10193489111163MEDLINESTGWLR2535JNTSTGWLR2535JNT2021-07-18
10193489111170MEDLINESTGWLR2535NTSTGWLR2535NT2021-07-18
10193489191653MEDLINEDYNDA2467DYNDA24672020-04-15
10193489196559MEDLINEMNS12330AMNS12330A2020-04-20
10653160343806MEDLINEMNS12330AMNS12330A2020-07-06
10653160346760MEDLINEECVC7165AECVC7165A2021-05-20
10653160366577MEDLINECVI5045CVI50452023-09-28
20193489087793Medline80045075800450752021-05-12
20653160349492MEDLINEGW1850IGW1850I2021-12-16
10193489006728MEDLINEURO12575URO125752026-10-23
10197344219261MEDLINEDYNDSCL1500RDYNDSCL1500R2026-10-23
10653160395461MEDLINEDYNDC3514BDYNDC3514B2026-10-24
10653160395713MEDLINEEBSI1586BEBSI1586B2026-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160542064HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-28
10809160542071HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-28
10809160542088HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-28
10809160542095HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-28
10809160542163HALYARDAVID MEDICAL, INC.LRO2026-10-28
10809160542170HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-28
10809160542194HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-28
10809160542200HalyardAVID MEDICAL, INC.LRO2026-10-28
10885632542213SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-28
10809160541784HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541791HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541838HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541845HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541852HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541869HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541883HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541913HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541937HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541951HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541975HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541982HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541999HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160542002HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10885632541773SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-27
10198956515376CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956577282CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956578869CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956590359CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956592902CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956596214CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26