BloodSTOP BS-11

GUDID 20850744001115

BloodSTOP Hemostat 2"x4" (5cmX10cm)

Lifescience Plus, Inc.

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

• Primary Device ID: 20850744001115
• NIH Device Record Key: acfc2ce8-fb42-46b7-8746-6aa5b886c38a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BloodSTOP
• Version Model Number: BS-11
• Catalog Number: BS-11
• Company DUNS: 190600051
• Company Name: Lifescience Plus, Inc.
• Device Count: 20
• 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: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 Square inch
• Area/Surface Area: 8 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	00850744001111 [Primary]
GS1	10850744001118 [Unit of Use]
GS1	20850744001115 [Package]; Contains: 00850744001111; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072681

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]

• 30850744001297: BloodSTOP OTC Hemostat, 8 pcs 1"X1"(2.5cmx2.5cm), 2pcs 2"x2" (5cmX5cm)
• 20850744001184: BloodSTOP Hemostat mini-pads 2cmx2cm 4/pouch
• 20850744001139: BloodSTOP Hemostat 4"x8" (10cmX20cm)
• 20850744001122: BloodSTOP Hemostat 4"x4" (10cmX10cm)
• 20850744001115: BloodSTOP Hemostat 2"x4" (5cmX10cm)
• 20850744001108: BloodSTOP Hemostat 2"x2" (5cmX5cm) 20/bx
• 00850744001098: BloodSTOP Hemostat 1"x1" (2.5cmX2.5cm)
• 00850744001609: Advanced BloodSTOP CVS 5 count 1-2"x2",4-1"x1"