Intercept i2 Oral Fluid Collection Device

Basic Information

• Brand Name: Intercept i2 Oral Fluid Collection Device
• Primary DI: 00608337000917
• Version / Model: 3001-2661
• Company Name: Orasure Technologies, Inc.
• Labeler DUNS: 114152184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-29
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 98c43815-564d-48d3-bb40-d1ef4408baeb

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: Yes
• 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
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33721	Absorbent tipped applicator, non-sterile	A device intended for medical purposes which include, to apply medications to, or to take specimens from, a patient or an object. It is typically designed as an absorbent, non-sterile, swab on a wooden, paper, or plastic stick. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00608337000917	GS1
Package	10608337000914	GS1	carton	50	In Commercial Distribution
Package	30608337000918	GS1	carton	100	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius