FDA.reportPublic FDA data

CVS Advanced BloodSTOP

Primary DI
30850744001310
Brand
CVS Advanced BloodSTOP
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
CVS-832230
Catalog number
832230
Device description
CVS Advanced BloodSTOP hemostatic dressing, 5 count 1-2"x2",4-1"x1"
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
K071578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071578000BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17Lifescience Plus, Inc.2007-09-27QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30850744001310PackageGS1192In Commercial Distribution
00850744001319PrimaryGS10
10850744001316Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085074400131030850744001310
00850744001319008507440013198507440013190850744001319
1085074400131610850744001316

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
Area/Surface Area4Square inch

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8602873192audrey.vitale@lifescienceplus.com

Regulatory Flags#

DUNS number
062312574
Device count
5
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

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00050428250181CVS Health4969912023-09-01
00050428340769CVS Health 0504283407692026-05-20

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00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
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