FDA.reportPublic FDA data

MEDLINE

Primary DI
00653160354850
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA2981
Catalog number
DYNDA2981
Device description
CORD BLOOD KIT
Published
2022-08-19
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
OIBBlood and urine collection kit (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160354850PackageGS120In Commercial Distribution
10653160354857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160354850006531603548506531603548500653160354850
1065316035485710653160354857

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253061039Aero-MedAERO-MED, LLCOIB2026-02-20
50192253061091Aero-MedAERO-MED, LLCOIB2026-02-20
50192253061107Aero-MedAERO-MED, LLCOIB2026-02-20
50192253061473Aero-MedAERO-MED, LLCOIB2026-02-20
50192253061480Aero-MedAERO-MED, LLCOIB2026-02-20
50192253061503Aero-MedAERO-MED, LLCOIB2026-02-20
50885380176119Aero-MedAERO-MED, LLCOIB2026-02-20
50885380185036Aero-MedAERO-MED, LLCOIB2026-02-20
50885380185067Aero-MedAERO-MED, LLCOIB2026-02-20
50885380185166Aero-MedAERO-MED, LLCOIB2026-02-20
50885380185180Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186521Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186569Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186590Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186644Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186668Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186675Aero-MedAERO-MED, LLCOIB2026-02-20
50885380187900Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188525Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188662Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188754Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188761Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188792Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189157Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189393Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189409Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189447Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189454Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189898Aero-MedAERO-MED, LLCOIB2026-02-20
50885380190979Aero-MedAERO-MED, LLCOIB2026-02-20