Home GUDID 10627595000825 ORAcollect Dx
Primary DI 10627595000825
Brand ORAcollect Dx
Company DNA Genotek Inc
Model OCD-100.014
Device description DNA Specimen Collection, Saliva
Published 2022-11-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name OYJ Dna Specimen Collection, Saliva
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OYJ Dna Specimen Collection, Saliva Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10627595000641 Package GS1 1 In Commercial Distribution 10627595000825 Package GS1 1 In Commercial Distribution 10627595001341 Package GS1 25 In Commercial Distribution 00627595000712 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10627595000641 10627595000641 10627595000825 10627595000825 10627595001341 10627595001341 00627595000712 00627595000712 627595000712 0627595000712
GMDN Terms# Term, Definition table Term Definition Oral/upper respiratory tract specimen collection swab A piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for culture, analysis, and/or other investigation. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 59 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 207983508 Device count 1 DM exempt false Premarket exempt false 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 false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# 
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