DEVICE: Chilling Block (10854913006089)
Device Identifier (DI) Information
Chilling Block
2 syringes + 2 vials
Not in Commercial Distribution
UROGEN PHARMA LTD
2 syringes + 2 vials
Not in Commercial Distribution
UROGEN PHARMA LTD
No description.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 64149 | Pharmaceutical cooling block |
A non-powered, countertop device made of metal materials with high thermal conductivity designed to hold and maintain at low temperatures [e.g., between -3 and 5° Celsius] vials and syringes used to prepare pharmaceutical solutions in the pharmacy or laboratory. It is in the form of a solid unit with slots/compartments for placing the vials/syringes after it has been stored in a freezer, typically overnight. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
18f4420a-c6eb-40da-af8c-ca9c46db989d
February 04, 2021
4
March 13, 2019
February 04, 2021
4
March 13, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 20854913006086 | 1 | 10854913006089 | 2021-02-03 | Not in Commercial Distribution | Carton Box |
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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined