FDA.reportPublic FDA data

Corning

Primary DI
H10835453
Brand
Corning
Company
CORNING INCORPORATED
Model
3545
Catalog number
3545
Device description
DISPOSABLE SIDE-ARM ASSEMBLY,MPC,1L
Published
2020-12-02
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
KJAFlask, tissue culture
KJESPINNER SYSTEM, CELL CULTURE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H10835453PackageHIBCC2In Commercial Distribution
H10835451PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA durable, sterile plastic container with ports, or glass bottle, 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. The device provides a suitable closed environment to reduce the risk of contamination and, if applicable, for cell growth/viability during storage that may or may not involve freezing. A device intended for cryopreservation is typically designed for long-term storage in a freezing system. A device intended for culture is typically gas permeable and may have an inner surface that enables adherence. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
001111103
Device count
1
DM exempt
true
Premarket exempt
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H10835151Corning351535152026-06-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H10835151CorningCorning IncorporatedKJE2026-06-05
H108117971CorningCorning IncorporatedKJA2026-06-03
H108117981CorningCorning IncorporatedKJA2026-06-03
H108117991CorningCorning IncorporatedKJA2026-06-03
H108118251CorningCorning IncorporatedKJA2026-04-01
H108110901CorningCorning IncorporatedKJA2026-02-26
H108110961CorningCorning IncorporatedKJA2026-02-26
H108117801CorningCorning IncorporatedKJA2026-02-26
H108115131CorningCorning IncorporatedKJA2026-01-05
H108115161CorningCorning IncorporatedKJA2026-01-05
H108115761CorningCorning IncorporatedKJA2026-01-05
H108115041CorningCorning IncorporatedKJA2025-10-28
H108115151CorningCorning IncorporatedKJA2025-10-28
H108115211CorningCorning IncorporatedKJA2025-10-28
H108117091CorningCorning IncorporatedKJA2025-10-28
H108117231CorningCorning IncorporatedKJA2025-10-28
H108117081CorningCorning IncorporatedKJA2025-07-07
H108116301CorningCorning IncorporatedKJA2025-05-15
H108116401CorningCorning IncorporatedKJA2025-05-15
H108115121CorningCorning IncorporatedKJA2025-04-16
H108118781CorningCorning IncorporatedKJA2025-01-22
H108112001CorningCorning IncorporatedKJA2024-12-23
H108117601CorningCorning IncorporatedKJA2024-07-25
H108117611CorningCorning IncorporatedKJA2024-07-25
H108117621CorningCorning IncorporatedKJA2024-07-25
H108117571CorningCorning IncorporatedKJA2024-01-18
H108117581CorningCorning IncorporatedKJA2023-12-01
H108117591CorningCorning IncorporatedKJA2023-12-01
H108117651CorningCorning IncorporatedKJA2023-10-09
H108117661CorningCorning IncorporatedKJA2023-10-09