FDA.reportPublic FDA data

Corning

Primary DI
H10820021CV3
Brand
Corning
Company
MEDIATECH, INC.
Model
20-021-CV
Catalog number
20-021-CV
Device description
Corning® 500 mL HBSS (Hanks Balanced Salt Solution), 10x [-] sodium bicarbonate, calcium, magnesium
Published
2020-12-04
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
KIPFORMULATIONS, BALANCED SALT SOLUTIONS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIPFormulations, Balanced Salt SolutionsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H10820021CV3PackageHIBCC6In Commercial Distribution
H10820021CV1PrimaryHIBCC0
H10820021CV0Unit of UseHIBCC0

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

Contacts#

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

Regulatory Flags#

DUNS number
181302050
Device count
6
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H10820021CV1Corning20-021-CV2020-12-04
H10840215CV1Corning40-215-CV2020-12-04
H10840215CV3Corning40-215-CV40-215-CV2020-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979203760278Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdKIP2026-01-07
05407010128505DPBS 0.0095M(PO4) w/o Ca,Mg-500mL sampleLonza VerviersKIP2025-08-20
05407010127454PBS w/o Ca-Mg 5L JerrycanLonza VerviersKIP2025-06-11
05407010127461PBS w/o Ca-Mg 1L bottleLonza VerviersKIP2025-06-11
05407010127478PBS w/o Ca-Mg Tween 20 0.1% 5L jerrycanLonza VerviersKIP2025-06-11
05407010127485Physiologic Water Tween20 0.05% 5LjerrycLonza VerviersKIP2025-06-11
05407010127492DPBS 1X with 1M NaCl - 10 L BagLonza VerviersKIP2025-06-11
05407010127508DPBS 1X - 20 L Bag Lonza VerviersKIP2025-06-11
05407010127515DPBS 1X with 0.06M NaCl - 20L bagLonza VerviersKIP2025-06-11
05407010127522DPBS 1X with 0.4M NaCl - 20L bagLonza VerviersKIP2025-06-11
05407010127539DPBS 1X with 0.08M NaCl - 10 L bagLonza VerviersKIP2025-06-11
05407010127546IBEX PBS : 1000L BagLonza VerviersKIP2025-06-11
05407010127553IBEX PBS : 1L Bag SAMPLELonza VerviersKIP2025-06-11
05407010127560DPBS IC51 1L bagLonza VerviersKIP2025-06-11
05407010127577DPBS IC51 20LLonza VerviersKIP2025-06-11
05407010127133DPBS 0.0095M(PO4) w/o Ca,Mg,500mlINTERNELonza VerviersKIP2025-05-26
05407010127140DPBS 0.0095M(PO4) w/o Ca, Mg, 1L INTERNELonza VerviersKIP2025-05-26
05407010126938DPBS 0.0095M(PO4) w/o Ca,Mg-250ml sample Lonza VerviersKIP2025-05-14
05407010126174NCTF Powder - 5LLonza VerviersKIP2025-03-20
05407010125726NCTF Powder - 380gLonza VerviersKIP2025-01-08
16974488990713iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
16974488990720iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
06974488990716iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
06974488990723iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
10190302001069Phosphate-Buffered Saline (PBS) (1X), pH 7.4LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002660Hanks’ Balanced Salt Solution (HBSS) (1X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002707Dulbecco’s Phosphate Buffered Saline (D-PBS) (1X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002714Dulbecco’s Phosphate Buffered Saline (D-PBS) (1X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002752Hanks’ Balanced Salt Solution (HBSS) (10X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002776Dulbecco’s Phosphate Buffered Saline (D-PBS) (10X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02