BloodSTOP iX BS-iX-17W

GUDID 00850744001630

BloodSTOP IX Advanced Hemostatic Wound Dressing 4"x8"(10cmX20cm)

Lifescience Plus, Inc.

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

• Primary Device ID: 00850744001630
• NIH Device Record Key: e78c5088-61a2-4117-9e25-fd4f05ce31f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BloodSTOP iX
• Version Model Number: BS-iX-17W
• Catalog Number: BS-iX-17W
• 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: false
• OTC Over-The-Counter: true

Device Dimensions

• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 Square inch
• Area/Surface Area: 32 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	00850744001630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071578

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]

• 00850744001647: BloodSTOP IX Advanced Hemostatic Wound Dressing 2"x14"(5cmX35cm)
• 00850744001630: BloodSTOP IX Advanced Hemostatic Wound Dressing 4"x8"(10cmX20cm)
• 00850744001623: BloodSTOP IX Advanced Hemostatic Wound Dressing 2"x4"(5cmX10cm)
• 10850744001286: BloodSTOP iX Hemostat surgical 0.5"X2" (1.3cmX5cm)
• 10850744001279: BloodSTOP iX Hemostat surgical 2"X14" (5cmX35cm)
• 10850744001262: BloodSTOP iX Hemostat surgical 4"X8" ( 10cmX20cm)
• 10850744001255: BloodSTOP iX Hemostat surgical 2"X4" (5cmX10cm)
• 10850744001248: BloodSTOP Ix Hemostat surgical 2"X2" (5cmX5cm)
• 00850744001142: BloodSTOP IX Advanced Hemostatic Wound Dressing 2"x2"(5cmX5cm)
• 00850744001401: BloodSTOP IX Donor Seal 4.5"X15" (11.5cmX37.5cm) z-folded 5 layers single pouch