Cue Sample Collection Kit

Basic Information

• Brand Name: Cue Sample Collection Kit
• Primary DI: 00810040820595
• Version / Model: C2243
• Company Name: Cue Health Inc.
• Labeler DUNS: 081257070
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-27
• Public Version: 3
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: fb5d5050-6376-4b54-90b9-3693bf2330f6

Device Description

Sample Collection Kit Dried Blood Spot Card and Kit Accessories

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65433	Capillary blood collection kit IVD	A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810040820595	GS1