FDA.reportPublic FDA data

BloodSTOP iX

Primary DI
10850744001286
Brand
BloodSTOP iX
Company
Lifescience Plus, Inc.
Model
BS-iX-27
Catalog number
BS-iX-27
Device description
BloodSTOP iX Hemostat surgical 0.5"X2" (1.3cmX5cm)
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00850744001289PrimaryGS10
10850744001286Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850744001289008507440012898507440012890850744001289
1085074400128610850744001286

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
24
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00850744001098BloodSTOPBS-09BS-092022-12-08
00850744001142BloodSTOP iXBS-iX-14NBS-iX-14N2022-12-08

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Primary DI, Brand, Company table
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00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
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04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
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10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
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10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29