Intercept i2 Oral Fluid Collection Device

GUDID 00608337000917

Orasure Technologies, Inc.

Absorbent tipped applicator, non-sterile
Primary Device ID00608337000917
NIH Device Record Key98c43815-564d-48d3-bb40-d1ef4408baeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntercept i2 Oral Fluid Collection Device
Version Model Number3001-2661
Company DUNS114152184
Company NameOrasure Technologies, Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100608337000917 [Primary]
GS110608337000914 [Package]
Package: carton [50 Units]
In Commercial Distribution
GS130608337000918 [Package]
Package: carton [100 Units]
In Commercial Distribution

FDA Product Code

NNKContainer, Specimen Mailer And Storage, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-07-29

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