Mawi DNA Technologies

Basic Information

• Brand Name: Mawi DNA Technologies
• Primary DI: 00850040712049
• Version / Model: ISWAB-DSC
• Catalog Number: ISWAB-DSC
• Company Name: Mawi Dna Technologies, LLC
• Labeler DUNS: 005460723
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-06
• Public Version: 1
• Public Version Date: 2022-04-14
• Public Version Status: New
• Public Device Record Key: b7122342-1d49-4b5f-8dda-a7a8bb50d821

Device Description

iSWAB-Discovery Human DNA Collection Kit 400 ul

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NNL	Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62691	Molecular grade buffered sample diluent IVD	A molecular grade buffered solution intended to be used for dilution of a clinical specimen, prior to or during an assay using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850040712049	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius