Accessory Sponges

GUDID 00627595000682

DNA Assisted Collection, Sponges

DNA Genotek Inc

Oral/upper respiratory tract specimen collection swab
Primary Device ID00627595000682
NIH Device Record Keyee736487-527f-4d6a-a5c3-d34829328eb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccessory Sponges
Version Model NumberOG-AC1
Company DUNS207983508
Company NameDNA Genotek Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100627595000682 [Primary]

FDA Product Code

KXFApplicator, Absorbent Tipped, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-29
Device Publish Date2022-11-21

Devices Manufactured by DNA Genotek Inc

00627595001627 - Colli-Pee2024-12-17 Urine Collection Container
00627595001634 - Colli-Pee2024-12-17 Urine Collection Container
00627595001641 - Colli-Pee2024-12-17 Urine Collection Container
00627595001658 - Colli-Pee2024-12-17 Urine Collection Container
00627595001665 - Colli-Pee2024-12-17 Urine Collection Container
00627595001672 - Colli-Pee2024-12-17 Urine Collection Container
00627595001689 - Colli-Pee2024-12-17 Urine Collection Container
00627595001696 - Colli-Pee2024-12-17 Urine Collection Container

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