FDA.reportPublic FDA data

Accessory Sponges

Primary DI
00627595000682
Brand
Accessory Sponges
Company
DNA Genotek Inc
Model
OG-AC1
Device description
DNA Assisted Collection, Sponges
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627595000682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627595000682006275950006826275950006820627595000682

GMDN Terms#

Term, Definition table
TermDefinition
Oral/upper respiratory tract specimen collection swabA 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
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-813-6354info@dnagenotek.com

Regulatory Flags#

DUNS number
207983508
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627595000279Oragene DxOXD-5002025-09-08
00627595000286Oragene DxOYD-5002025-09-08
00627595001627Colli-PeeColli-Pee FV-5020N000552024-12-09
00627595001634Colli-PeeColli-Pee FV-5010N003092024-12-09
00627595001641Colli-PeeColli-Pee FV-5020cN002382024-12-09
00627595001658Colli-PeeColli-Pee FV-5004N002902024-12-09
00627595001665Colli-PeeColli-Pee FV-5040N002692024-12-09
00627595001672Colli-PeeColli-Pee UCM FV-5020N001762024-12-09
00627595001689Colli-PeeColli-Pee UCM FV-5010N003272024-12-09
00627595001696Colli-PeeColli-Pee UCM FV-5003bN003832024-12-09
00627595001702Colli-PeeColli-Pee UCM FV-5004N002602024-12-09
00627595001719Colli-PeeColli-Pee UAS FV-5040N003422024-12-09
00627595000507OMNIgene GUT DxOMD-2002022-11-18
00627595000712ORAcollect DxOCD-100.0142022-11-18
00627595000132Oragene DxOGD-5102016-09-08
00627595000248Oragene DxOGD-6002016-09-09
00627595000255Oragene DxOGD-6102016-09-09
00627595000309ORAcollect DxOCD-1002016-09-10
00627595000316ORAcollect DxOCD-100A2022-11-18
00627595000675OMNIgene ORALOME-5052022-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10609576801294Hospital®Puritan Medical ProductsKXF2026-07-31
10609576300018Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576330657Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576330725Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576331098Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576331111Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576331418Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576331432Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576331449Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576331586Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576340007Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576360203Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576360210Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576360241Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576360265Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576800068Puritan®Puritan Medical ProductsKXF2026-07-20
10609576800075Puritan®Puritan Medical ProductsKXF2026-07-20
10609576800297Puritan®Puritan Medical ProductsKXF2026-07-20
10609576800570Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800024Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800048Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800055Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800109Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800130Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800161Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800185Puritan® CalgiSwab®Puritan Medical ProductsKXF2026-07-20
30609576800208Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800406Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800543Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800604Puritan®Puritan Medical ProductsKXF2026-07-20