FDA.reportPublic FDA data

QuiCover

Primary DI
06972060310235
Brand
QuiCover
Company
Hangzhou Zeo-Innov Life Technology Co., Ltd.
Model
P0910122
Device description
The Zeolite Hemostatic Gauze consists of zeolite and gauze. Zeolite Hemostatic Gauze is provided in a sterile dressing format that conforms readily to the wound. It is available in four types, which are P (Sheet), J (Rolled), Z (Folded) and L (Cubed). The difference between each type is the dressing shape. Each type is available in a range of different sizes.
Published
2022-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K211570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211570000Zeolite Hemostatic GauzeHangzhou Zeo-Innov Life Technology Co., Ltd.2022-02-10QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972060310235PackageGS110In Commercial Distribution
06972060310242PackageGS110In Commercial Distribution
06972060310259PackageGS16In Commercial Distribution
06972060310174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972060310235069720603102356972060310235
06972060310242069720603102426972060310242
06972060310259069720603102596972060310259
06972060310174069720603101746972060310174

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(360)325 7028us.agent@mid-link.net

Regulatory Flags#

DUNS number
541290694
Device count
1
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972060310532QuiCover0.3g2024-04-22
06972060310457QuiCoverP-9cm×10cm-12,2 pieces/bag2023-09-01
06972060310464QuiCoverP-9cm×10cm-12,2 pieces/bag2023-09-01
06972060310174QuiCoverP09101222022-06-07

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