Primary Device ID | B199GDKRYO360331150 |
NIH Device Record Key | e527bdc8-e838-44e2-9de2-f7a5a0cca9bf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Kryo 360 Freezer |
Version Model Number | GDKRYO360-3.3-115 |
Company DUNS | 217190495 |
Company Name | PLANER LIMITED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B199GDKRYO360331150 [Primary] |
KSP | Apparatus, Cell-Freezing And Reagents |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-10-28 |
Device Publish Date | 2016-09-23 |
B199GDKRYO360CH331150 | Kryo 360 Controlled Rate Freezer. 3.3 litre Chamber Only |
B199GDKRYO360CH171150 | Kryo 360 Controller Rate Freezer - 1.7 Chamber Only |
B199GDKRYO36033115DT0 | Kryo 360 Controlled Rate Freezer. 3.3 Litre Chamber. |
B199GDKRYO360331150 | Kryo 360 Controlled Rate Freezer. 3.3 Litre Chamber |
B199GDKRYO36017115DT0 | Kryo 360 Controlled Rate Freezer. 1.7 Litre Chamber |
B199GDKRYO360171150 | Kryo 360 Controlled Rate Freezer. 1.7 Litre Chamber |