FDA.reportPublic FDA data

Mawi DNA Technologies

Primary DI
00850040712179
Brand
Mawi DNA Technologies
Company
Mawi Dna Technologies, LLC
Model
NextSWAB-2
Catalog number
NextSWAB-2
Device description
NextSWAB, 2-pack
Published
2022-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00850040712179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040712179008500407121798500407121790850040712179

GMDN Terms#

Term, Definition table
TermDefinition
Oral/upper respiratory tract specimen collection swab IVDAn in vitro diagnostic device in the form of 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 in vitro diagnostic investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
510-256-5186support@mawidna.com

Regulatory Flags#

DUNS number
005460723
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040712018Mawi DNA TechnologiesISD-T-1200ISD-T-12002022-04-06
00850040712032Mawi DNA TechnologiesISD-T-250ISD-T-2502022-04-06
00850040712063Mawi DNA TechnologiesISF-T-250ISF-T-2502022-04-06
00850040712070Mawi DNA TechnologiesISF-T-DSCISF-T-DSC2022-04-06
00850040712094Mawi DNA TechnologiesISR2-T-1200ISR2-T-12002022-04-06
00850040712001Mawi Dna TechnologiesiSWAB-DNA-1200iSWAB-DNA-12002022-04-06
00850040712025Mawi DNA TechnologiesISWAB-DNA-250ISWAB-DNA-2502022-04-06
00850040712049Mawi DNA TechnologiesISWAB-DSCISWAB-DSC2022-04-06
00850040712056Mawi DNA TechnologiesISWAB-ID-250ISWAB-ID-2502022-04-06
00850040712087Mawi DNA TechnologiesISWAB-RNA-v2ISWAB-RNA-v22022-04-06
00850040712124Mawi DNA TechnologiesISM-T-1200ISM-T-12002022-04-06
00850040712131Mawi DNA TechnologiesISM-T-ELISM-T-EL2022-04-06
00850040712155Mawi DNA TechnologiesISC-T-1200ISC-T-12002022-04-06
10850040712015Mawi DNA TechnologiesISD-T-1200ISD-T-12002022-04-06
10850040712039Mawi DNA TechnologiesISD-T-250ISD-T-2502022-04-06
10850040712060Mawi DNA TechnologiesISF-T-250ISF-T-2502022-04-06
10850040712077Mawi DNA TechnologiesISF-T-DSCISF-T-DSC2022-04-06
10850040712091Mawi DNA TechnologiesISR2-T-1200ISR2-T-12002022-04-06
00850040712100Mawi DNA TechnologiesiSWAB-MB-1200iSWAB-MB-12002022-04-06
00850040712117Mawi DNA TechnologiesiSWAB-MBF-1200iSWAB-MBF-12002022-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971893320473Disposable Sampling SwabMIRACLEAN TECHNOLOGY CO., LTD.KXG2026-08-26
06971893320794Disposable Sampling SwabMIRACLEAN TECHNOLOGY CO., LTD.KXG2026-08-26
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