FDA.reportPublic FDA data

Kashi Scientific

Primary DI
00850039389160
Brand
Kashi Scientific
Company
Kashi Scientific, LLC
Model
2207
Catalog number
106A0
Device description
Sampling Flocked Swab - Sterile
Published
2022-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXGApplicator, Absorbent Tipped, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXGApplicator, Absorbent Tipped, SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850039389160PackageGS1100In Commercial Distribution
00850039389177PackageGS110000In Commercial Distribution
00850039389153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850039389160008500393891608500393891600850039389160
00850039389177008500393891778500393891770850039389177
00850039389153008500393891538500393891530850039389153

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(888) 280-1126info@kashiscientific.com

Regulatory Flags#

DUNS number
110618994
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850039389023Kashi Scientific2201103C-XS2022-01-30
00850039389054Kashi Scientific2201103C-S2022-01-30
00850039389085Kashi Scientific2201103C-M2022-01-30
00850039389115Kashi Scientific2201103C-L2022-01-30
00850039389139Kashi Scientific2201103C-XL2022-01-30
00850039389153Kashi Scientific2207106A02022-07-14
00860008024459Kashi Scientific2112106C02022-01-01
00850039389030Kashi Scientific2201103C-XS2022-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00609576381164Puritan®Puritan Medical ProductsKXG2026-07-31
10609576901789QuickVuePuritan Medical ProductsKXG2026-07-31
30609576380618Hospital®Puritan Medical ProductsKXG2026-07-31
00609576381119Puritan®Puritan Medical ProductsKXG2026-07-27
00609576381133Puritan®Puritan Medical ProductsKXG2026-07-27
00609576381423Puritan®Puritan Medical ProductsKXG2026-07-27
00609576381676Puritan®Puritan Medical ProductsKXG2026-07-27
00609576901799Puritan®Puritan Medical ProductsKXG2026-07-27
30609576381196Puritan®Puritan Medical ProductsKXG2026-07-27
30609576380601Hospital®Puritan Medical ProductsKXG2026-07-20
30609576380809Puritan®Puritan Medical ProductsKXG2026-07-20
50609576901701cobas Dual SwabsPuritan Medical ProductsKXG2026-07-20
00810124537616VaklyAvaline Medical NJ Limited Liability CompanyKXG2026-07-16
00609576010132BD AffirmPuritan Medical ProductsKXG2026-07-08
00609576381539Puritan®Puritan Medical ProductsKXG2026-07-08
00609576381782Puritan®Puritan Medical ProductsKXG2026-07-08
00609576390302Puritan®Puritan Medical ProductsKXG2026-07-08
10609576380362Puritan®Puritan Medical ProductsKXG2026-07-08
10609576381413Puritan®Puritan Medical ProductsKXG2026-07-08
00884999051737RealTimeABBOTT MOLECULAR INC.KXG2026-07-06
00884999051744Alinity mABBOTT MOLECULAR INC.KXG2026-07-06
00609576010378BD ProbeTecPuritan Medical ProductsKXG2026-07-02
00609576390142PuritanPuritan Medical ProductsKXG2026-07-02
00609576360251Puritan® Dry Transport System Sterile Flocked Collection DevicePuritan Medical ProductsKXG2026-05-29
08809262391039Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391053Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391060Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391077Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391329Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391336Specimen Collection SwabHLB CO.,LTDKXG2025-10-28