FDA.reportPublic FDA data

Corning

Primary DI
H10835151
Brand
Corning
Company
Corning Incorporated
Model
3515
Catalog number
3515
Device description
Disposable Aseptic Transfer Cap for 500ml Polystyrene Spinner Flask, custom 0.2µm vent filter, Male Luer Lock connector, Sterile, 1 per bag, 2 per case
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KJESPINNER SYSTEM, CELL CULTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJESpinner System, Cell CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H10835153PackageHIBCC2In Commercial Distribution
H10835151PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)492-1110scientificsupport@corning.com

Regulatory Flags#

DUNS number
001307735
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
H108117971Corning11797117972026-06-03
H108117981Corning11798117982026-06-03
H108117991Corning11799117992026-06-03
H108118081Corning11808118082020-12-02
H108118091Corning11809118092020-12-02
H108118101Corning11810118102020-12-02
H10874071Corning740774072022-03-15
20389151000249Corning® PureCoat™3567323567322019-04-26
20389151000263Corning® PureCoat™3567733567732019-04-26
20389151000270Corning® PureCoat™3567753567752019-04-26
20389151000287Corning® PureCoat™3567783567782019-04-26
20389151000300Corning® PureCoat™3567843567842019-04-26
20389151000348Corning® PureCoat™3562403562402019-04-26
20389151000355Corning® PureCoat™3562413562412019-04-26
20389151000386Corning® PureCoat™3562443562442019-04-26
20389151000478Corning® PureCoat™3562743562742019-04-26
20389151000119Corning® PureCoat™3547323547322019-04-26
20389151000133Corning® PureCoat™3547733547732019-04-26
20389151000140Corning® PureCoat™3547753547752019-04-26
20389151000157Corning® PureCoat™3547783547782019-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H108119151CorningCorning IncorporatedKJE2020-12-02
H108119161CorningCorning IncorporatedKJE2020-12-02
H108119171CorningCorning IncorporatedKJE2020-12-02
H108130061CorningCorning IncorporatedKJE2020-12-02
H108130071CorningCorning IncorporatedKJE2020-12-02
H108130091CorningCorning IncorporatedKJE2020-12-02
H10835281CorningCorning IncorporatedKJE2020-12-02
H10835451CorningCorning IncorporatedKJE2020-12-02
H10835461CorningCorning IncorporatedKJE2020-12-02
H10835581CorningCorning IncorporatedKJE2020-12-02
H10835591CorningCorning IncorporatedKJE2020-12-02
H10835611CorningCorning IncorporatedKJE2020-12-02
H10835621CorningCorning IncorporatedKJE2020-12-02
H10835631CorningCorning IncorporatedKJE2020-12-02
H10835641CorningCorning IncorporatedKJE2020-12-02
H10835651CorningCorning IncorporatedKJE2020-12-02
H10835691CorningCorning IncorporatedKJE2020-12-02
H10835791CorningCorning IncorporatedKJE2020-12-02
H10835801CorningCorning IncorporatedKJE2020-12-02
H10835811CorningCorning IncorporatedKJE2020-12-02
H10836451CorningCorning IncorporatedKJE2020-12-02
H10871741CorningCorning IncorporatedKJE2020-12-02
H108119153CorningCORNING INCORPORATEDKJE2020-12-02
H108119163CorningCORNING INCORPORATEDKJE2020-12-02
H108119173CorningCORNING INCORPORATEDKJE2020-12-02
H108130063CorningCORNING INCORPORATEDKJE2020-12-02
H108130073CorningCORNING INCORPORATEDKJE2020-12-02
H108130093CorningCORNING INCORPORATEDKJE2020-12-02
H10835283CorningCORNING INCORPORATEDKJE2020-12-02
H10835453CorningCORNING INCORPORATEDKJE2020-12-02