FDA.reportPublic FDA data

Cell Freeze

Primary DI
00817827023538
Brand
Cell Freeze
Company
CHARTER MEDICAL, LTD.
Model
CF-500
Catalog number
CF-500
Device description
Cell Freeze Cryogenic Storage Container 500 mL Capacity
Published
2021-08-23
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
LPZContainer, Frozen Donor Tissue Storage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPZContainer, Frozen Donor Tissue StorageUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1000490

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1000490

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817827023538PackageGS140In Commercial Distribution
00817827023033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817827023538008178270235388178270235380817827023538
00817827023033008178270230338178270230330817827023033

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
(866) 458-3116cml_customerservice@chartermedical.com

Regulatory Flags#

DUNS number
029062325
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
true
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
00817827023019Cell FreezeCF-250CF-2502021-08-23
00817827023026Cell FreezeCF-250-3LCF-250-3L2021-08-23
00817827023033Cell FreezeCF-500CF-5002021-08-23
00817827023040Cell FreezeCF-500-3LCF-500-3L2021-08-23
00817827023057Cell FreezeCF-50CF-502021-08-23
00817827023064Cell FreezeCF-750CF-7502021-08-23
00817827023088Cell FreezeCML-75LNCML-75LN2021-08-23
00817827025044N/AC600C6002016-09-24
00817827025051N/AC605C6052016-09-24
00817827025129N/AT3006T30062016-09-24
00817827025136N/AT3101T31012016-09-24
00817827025143N/AT3104T31042016-09-24
00817827025150N/AT3106T31062016-09-24
00817827025167N/AT3106X2T3106X22016-09-24
00817827025174N/AT3107T31072016-09-24
00817827025181N/AT3108T31082016-09-24
00817827025198N/AT3109T31092016-09-24
00817827025204N/AT3110T31102016-09-24
00817827025211N/AT3194T31942016-09-24
00817827025228N/AT3400T34002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816203023923PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203023930PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203024104PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203024128PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203024340PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203024357PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203023920PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203023937PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203024101PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203024125PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203024347PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203024354PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
10816203023657PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023664PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023671PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023688PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023695PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023701PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023718PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023602PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023619PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023626PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023633PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023596PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023609PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023616PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023623PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023630PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
00817827023019Cell FreezeCHARTER MEDICAL, LTD.LPZ2021-08-23
00817827023026Cell FreezeCHARTER MEDICAL, LTD.LPZ2021-08-23