FDA.report

QuadraView

Primary DI
06973166110057
Company
CompAI Healthcare (Shenzhen) Co.,ltd
Model
100
Device description
Specimen Container
Published
2021-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Regulatory Flags

DUNS number
554511443
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
16973166110054PackageGS110In Commercial Distribution
06973166110057PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
16973166110054PackageGS110Box06973166110057In Commercial Distribution
06973166110057PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
NNIContainer, Specimen, Non-Sterile1Pathology864.3250NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
General tissue specimen container IVD, no additiveA covered receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
+8651267236750support@comp-ai.com

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06973166110033QudraView1002021-05-03
06973166110026TrueView100 Pro2021-01-22

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