Oratect Oral Fluid Collection Tube CM-190

GUDID 00816555020208

Oral Fluid Specimen Collection Tube

BRANAN MEDICAL CORPORATION

Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD
Primary Device ID00816555020208
NIH Device Record Keye8aaf453-7b5d-41ba-97f2-35989cade4db
Commercial Distribution Discontinuation2018-10-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOratect Oral Fluid Collection Tube
Version Model NumberCM-190
Catalog NumberCM-190
Company DUNS184347305
Company NameBRANAN MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.
Special Storage Condition, SpecifyBetween 0 and 0 *Store collected specimen between 2 to 8 degrees celcius.

Device Identifiers

Device Issuing AgencyDevice ID
GS100816555020208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDJEnzyme Immunoassay, Cannabinoids

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-02
Device Publish Date2016-07-29

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