BRAT 2

GUDID 38033178106260

SORIN GROUP ITALIA SRL

Red blood cell-recovery autotransfusion system container

• Primary Device ID: 38033178106260
• NIH Device Record Key: 82ece046-5de6-40fa-b4a6-5f3e58b47bf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRAT 2
• Version Model Number: RESERVOIR WITH OUTLET CLAMP 30 µm
• Company DUNS: 442126587
• Company Name: SORIN GROUP ITALIA SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033178106269 [Primary]
GS1	38033178106260 [Package]; Contains: 08033178106269; Package: BOX [6 Units]; In Commercial Distribution

FDA Product Code

• CAC: APPARATUS, AUTOTRANSFUSION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-01-08
• Device Publish Date: 2015-07-06

On-Brand Devices [BRAT 2]

• 38033178109728: PROCEDURE SET (CYA)- 120 µm/250 ml
• 38033178109711: PROCEDURE SET (20 ft) - 30 µm/250 ml
• 38033178106260: RESERVOIR WITH OUTLET CLAMP 30 µm
• 38033178106253: RESERVOIR WITH OUTLET CLAMP 120 µm
• 38033178106246: STANDBY COLLECTION SET - 30 µm
• 38033178106239: STANDBY COLLECTION SET - 120 µm
• 38033178106055: BOWL PROCESSING SET - 250 ml
• 38033178106048: BOWL PROCESSING SET - 135 ml
• 38033178106017: PROCEDURE SET - 30 µm/250 ml
• 38033178106000: PROCEDURE SET - 120 µm/250 ml
• 38033178105980: PROCEDURE SET - 30 µm/135 ml
• 38033178105973: PROCEDURE SET - 120 µm/135 ml