Mawi DNA Technologies

Basic Information

• Brand Name: Mawi DNA Technologies
• Primary DI: 00850040712032
• Version / Model: ISD-T-250
• Catalog Number: ISD-T-250
• 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: 2804fe1f-40d8-4cf0-a595-4d649747e0b0

Device Description

iSWAB DNA Collection Tube 600 ul

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
Package	10850040712039	GS1	Rack	50	In Commercial Distribution
Primary	00850040712032	GS1
Package	20850040712036	GS1	Bag	500	In Commercial Distribution

Customer Contacts

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

Storage Conditions

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