RESPDIRECT™

Basic Information

• Brand Name: RESPDIRECT™
• Primary DI: 25420045516691
• Version / Model: RESPDIRECT COLLECTION KIT, US-KIT, BOX
• Catalog Number: PRD-07788
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-08-14
• Public Version: 1
• Public Version Date: 2023-08-22
• Public Version Status: New
• Public Device Record Key: 3132ba3a-df1b-4a37-ad25-a89d1960b228

Device Description

RespDirect™ Collection Kit, 50 count.

Device Characteristics

• Single Use: No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• 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
QOF	Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents	Microbiology	866.3981	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58216	Oral/upper respiratory tract specimen collection kit IVD, clinical	A collection of devices intended exclusively for professional use to assist in the extraction/collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for in vitro diagnostic investigation. The kit consists of a non-suctioning specimen sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle/container(s) with or without an additive/medium [e.g., pre-rinse/irrigation solution, tartrazine colouring agent, transport microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	15420045516694	GS1
Primary	25420045516691	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K222736	000

Storage Conditions

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