FDA.report

Typenex Transport Tubes

Primary DI
00810050852333
Brand
Typenex Transport Tubes
Company
TYPENEX MEDICAL LLC
Model
TC0201XNS
Catalog number
TC0201XNS
Device description
Non-Sterile Transport Tube - 10 ML - Caps Separate
Published
2020-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810050852333PackageGS11000In Commercial Distribution
00810050852326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050852333008100508523338100508523330810050852333
00810050852326008100508523268100508523260810050852326

GMDN Terms

TermDefinition
General specimen receptacle transport containerA non-sterile, portable device designed for the transportation of one or multiple clinical specimen receptacles (e.g., glass vials, bottles, tubes, slides, swabs) from the point of collection to the laboratory or between medical institutions. It is typically designed to be liquid-tight with a shock-absorbing foam liner to protect the contents from adverse conditions that could cause breakage and to absorb any escaped fluid. It is available in a variety of sizes, shapes, and materials. This is a reusable device.

Device Sizes

TypeValueUnit
Total Volume10Milliliter

Sterilization Methods

Method

Regulatory Flags

DUNS number
600850213
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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