Home GUDID 10627595000313 ORAcollect Dx
Primary DI 10627595000313
Brand ORAcollect Dx
Company DNA Genotek Inc
Model OCD-100A
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 00627595001009 Package GS1 1 In Commercial Distribution 00627595001023 Package GS1 1 In Commercial Distribution 00627595001047 Package GS1 1 In Commercial Distribution 00627595001061 Package GS1 1 In Commercial Distribution 10627595000313 Package GS1 25 In Commercial Distribution 10627595001013 Package GS1 25 In Commercial Distribution 10627595001037 Package GS1 25 In Commercial Distribution 10627595001051 Package GS1 25 In Commercial Distribution 10627595001075 Package GS1 25 In Commercial Distribution 00627595000316 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 00627595001009 00627595001009 627595001009 0627595001009 00627595001023 00627595001023 627595001023 0627595001023 00627595001047 00627595001047 627595001047 0627595001047 00627595001061 00627595001061 627595001061 0627595001061 10627595000313 10627595000313 10627595001013 10627595001013 10627595001037 10627595001037 10627595001051 10627595001051 10627595001075 10627595001075 00627595000316 00627595000316 627595000316 0627595000316
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 68 Degrees Fahrenheit 78 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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