FDA.reportPublic FDA data

QuikClot

Primary DI
00841495106361
Brand
QuikClot
Company
Z-MEDICA, LLC
Model
0636
Catalog number
0636
Device description
QuikClot EMS 4x4 Dressing w/X-ray
Published
2021-02-10
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

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
K123387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123387000QUIKCLOT HEMOSTATIC DRESSINGZ-Medica, LLC2013-04-12QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30841495106362PackageGS110In Commercial Distribution
50841495106366PackageGS110In Commercial Distribution
00841495106361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084149510636230841495106362
5084149510636650841495106366
00841495106361008414951063618414951063610841495106361

GMDN Terms#

Term, Definition table
TermDefinition
Non-organic haemostatic agentA non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis through formation of a sealant and/or clot acceleration; it might additionally be intended to absorb bodily fluids. It is available in various forms (e.g., powder, gel, impregnated gauze) intended to be applied directly or endoscopically to the wound temporarily; it does not contain an antimicrobial agent. Disposable manual or electronic devices for application may be included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
877-750-0504quikclot-engineering@teleflex.com

Regulatory Flags#

DUNS number
079190073
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841495102899QuikClot028902892018-06-01
00841495103018QuikClot030103012018-06-01
00841495103025QuikClot030203022018-06-01
00841495103032QuikClot030303032018-06-01
00841495104596QuikClot045904592017-09-27
00841495105104QuikClot051005102021-08-18
00841495105388QuikClot053805382021-02-09
00841495105722QuikClot057205722021-02-09
00841495106323QuikClot063206322018-06-01
00841495106330QuikClot063306332018-06-01
00841495120107QuikClot201020102021-08-18
00841495140501QuikClot405040502021-08-18
00841495105340QuikClot053405342021-02-12
00841495105401QuikClot054005402021-02-12
00841495105418QuikClot054105412021-02-12
00841495105470QuikClot054705472021-02-12
00841495105487QuikClot054805482021-02-12
00841495102004QuikClot020002002021-02-10
00841495104992QuikClot049904992021-02-10
00841495105265QuikClot052605262021-02-10

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Primary DI, Brand, Company table
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00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
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00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08
00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
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