BloodSTOP iX Trauma Matrix BM-iX-24

GUDID 00850744001395

BloodSTOP IX Trauma Matrix 3"X24" (7.5cmX60cm) z-folded 8 layers

Lifescience Plus, Inc.

Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

• Primary Device ID: 00850744001395
• NIH Device Record Key: 4a66be5d-76e3-459b-8c6f-1c8af3547e48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BloodSTOP iX Trauma Matrix
• Version Model Number: BM-iX-24
• Catalog Number: BM-iX-24
• Company DUNS: 190600051
• Company Name: Lifescience Plus, Inc.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch
• Area/Surface Area: 72 Square inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850744001395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160130

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-12-04
• Device Publish Date: 2022-12-08

On-Brand Devices [BloodSTOP iX Trauma Matrix]

• 00850744001586: BloodSTOP IX Hemostat Trauma Care Matrix 12"X12" (30cmX30cm)
• 00850744001395: BloodSTOP IX Trauma Matrix 3"X24" (7.5cmX60cm) z-folded 8 layers
• 00850744001449: BloodSTOP iX Trauma Matrix Hemostat pre hospital 3.5"X21" ( 8.75cmX52.5cm) z-folded 6 layers si