FDA.reportPublic FDA data

MEDLINE

Primary DI
10193489141894
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
KYTO1515
Catalog number
KYTO1515
Device description
PATCH,KYTOMATRIX,HEMOSTATIC,1.5,INX1.5IN
Published
2024-07-16
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
QSYHemostatic wound dressing without thrombin or other biologics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489141891PackageGS110In Commercial Distribution
30193489141898PackageGS110In Commercial Distribution
10193489141894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348914189120193489141891
3019348914189830193489141898
1019348914189410193489141894

GMDN Terms#

Term, Definition table
TermDefinition
Chitosan haemostatic agent, professional, non-bioabsorbableA non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied exclusively by healthcare professionals in a clinical setting to traumatic wounds in emergency situations (e.g., road accidents, combat, emergency rescue) or during surgical intervention to produce a rapid haemostasis by forming a robust plug of gel which is removed after use. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
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
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

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00834061005267StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005274StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005281StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005298StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005304StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005366StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
00834061005373StatSeal®BIOLIFE, L.L.C.QSY2026-04-09
10841495150385QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
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34026704930082QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20
34026704930105QUIKCLOTTELEFLEX INCORPORATEDQSY2026-03-20