FDA.reportPublic FDA data

BloodSTOP

Primary DI
00850744001098
Brand
BloodSTOP
Company
Lifescience Plus, Inc.
Model
BS-09
Catalog number
BS-09
Device description
"BloodSTOP Hemostat 1""x1"" (2.5cmX2.5cm) "
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072681000BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZELifescience Plus, Inc.2007-11-02QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850744001092PackageGS120In Commercial Distribution
00850744001098PrimaryGS10
10850744001095Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085074400109220850744001092
00850744001098008507440010988507440010980850744001098
1085074400109510850744001095

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobialA non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area1Square inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
190600051
Device count
20
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850744001609BloodSTOP8322302024-07-10
00850744001364SealkSK-iX-342024-06-25
00850744001302SealkSK-iX-162024-06-25
10850744001361SealkSK-iX-342024-06-25
00850744001371SealkSK-iX-222024-06-25
00850744001401BloodSTOP iXBS-iX-232024-06-25
00850744001449BloodSTOP iX Trauma MatrixTM-iX-262024-06-25
00850744001104BloodSTOPBS-10BS-102022-12-08
00850744001111BloodSTOPBS-11BS-112022-12-08
00850744001128BloodSTOPBS-12BS-122022-12-08
00850744001135BloodSTOPBS-13BS-132022-12-08
00850744001180BloodSTOPBS-MP-18BS-MP-182022-12-08
00850744001241BloodSTOP iXBS-iX-14BS-iX-142022-12-08
00850744001258BloodSTOP iXBS-iX-15BS-iX-152022-12-08
00850744001265BloodSTOP iXBS-iX-17BS-iX-172022-12-08
00850744001272BloodSTOP iXBS-iX-20BS-iX-202022-12-08
00850744001289BloodSTOP iXBS-iX-27BS-iX-272022-12-08
00850744001296BloodSTOPBS-OTC-28BS-OTC-282022-12-08
00850744001142BloodSTOP iXBS-iX-14NBS-iX-14N2022-12-08
00850744001395BloodSTOP iX Trauma MatrixBM-iX-24BM-iX-242022-12-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4Sion Brands LLCFRO2026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4Sion Brands LLCFRO2026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz TubeSion Brands LLCFRO2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz TubeSion Brands LLCFRO2026-06-01
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09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
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09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
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10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
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