FDA.reportPublic FDA data

MEDLINE

Primary DI
10193489193794
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDH1472
Catalog number
DYNDH1472
Device description
BLOOD CULTURE KIT
Published
2020-04-23
Public version status
Update
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
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
20193489193791PackageGS120In Commercial Distribution
10193489193794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348919379120193489193791
1019348919379410193489193794

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)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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
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