AccessGUDID - DEVICE: Cell Freeze (00817827023019)

GUDID

Device Identifier (DI) Information

Brand Name: Cell Freeze
Version or Model: CF-250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CF-250
Company Name: CHARTER MEDICAL, LTD.

Primary DI Number: 00817827023019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 029062325 *Terms of Use

Device Description: Cell Freeze Cryogenic Storage Container 250 mL Capacity

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44904	Blood/tissue storage/culture container	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPZ	Container, Frozen Donor Tissue Storage

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK100049	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 227104b4-4963-4914-939d-cbd7509befc7
Public Version Date: June 17, 2022
Public Version Number: 2
DI Record Publish Date: August 23, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00817827023514	40	00817827023019		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 866-458-3116
Email: CML_customerservice@chartermedical.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES