FDA.report

MEDLINE

Primary DI
20197344020765
Company
MEDLINE INDUSTRIES, INC.
Model
DYND36456007
Catalog number
DYND36456007
Device description
TUBE,VACU,URINE,7ML,ROUND,STER, BACK CAP
Published
2024-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
025460908
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
20197344020765PackageGS110In Commercial Distribution
30197344020762PrimaryGS10
10197344020768Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
20197344020765PackageGS110CS30197344020762In Commercial Distribution
30197344020762PrimaryGS10
10197344020768Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
NNIContainer, Specimen, Non-Sterile1Pathology864.3250NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Evacuated urine specimen container IVD, no additiveA covered receptacle containing a pre-measured amount of vacuum with no additives, intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other in vitro diagnostic investigation. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Protect from freezing, Avoid excessive heat

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

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20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
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20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
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