FDA.report

MEDLINE

Primary DI
20193489197904
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDH1555
Catalog number
DYNDH1555
Device description
BLOOD CULTURE COLLECTION KIT
Published
2020-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OIBBlood and urine collection kit (excludes HIV testing)

Product Code Classifications

CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489197904PackageGS124In Commercial Distribution
10193489197907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348919790420193489197904
1019348919790710193489197907

GMDN Terms

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

Contacts

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
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
true
No natural rubber latex
false
Sterilization required before use
false

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10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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