DT Wash

GUDID 15391521421309

TCOAG IRELAND LIMITED

Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD

• Primary Device ID: 15391521421309
• NIH Device Record Key: 5c70a58b-4146-4647-b33f-85dd8c5fcd49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DT Wash
• Version Model Number: DTW
• Company DUNS: 985039126
• Company Name: TCOAG IRELAND LIMITED
• Device Count: 24
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391521421302 [Unit of Use]
GS1	15391521421309 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-08
• Device Publish Date: 2019-06-28

Devices Manufactured by TCOAG IRELAND LIMITED

• 15391521421286 - TriniLIZE™ Stabilyte tubes: 2019-07-19
• 15391521420470 - TriniCLOT Lupus Screen: 2019-07-08
• 15391521420487 - TriniCLOT Lupus Confirm: 2019-07-08
• 15391521420630 - TriniCHECK Level 1: 2019-07-08
• 15391521420647 - TriniCHECK Level 2: 2019-07-08
• 15391521420654 - TriniCHECK Level 3: 2019-07-08
• 15391521421309 - DT Wash: 2019-07-08
• 15391521421309 - DT Wash: 2019-07-08
• 15391521421729 - DT Fluid: 2019-07-08