Primary Device ID | B199GDCT37M5CO20 |
NIH Device Record Key | 1fd8b73b-d4ad-4e4e-9291-b59afcf34507 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CT37 Incubator |
Version Model Number | GDCT37-M-5-CO2 |
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 | B199GDCT37M5CO20 [Primary] |
PUB | Accessory, Assisted Reproduction, Exempt |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-10-28 |
Device Publish Date | 2018-04-03 |
B199GDCT37M6CO20 | CT37Stax Incubator |
B199GDCT37M60 | CT37Stax Incubator |
B199GDCT37M5CO20 | CT37stax Incubator |
B199GDCT37M50 | CT37Stax Incubator |
B199GDCT37M4CO20 | CT37Stax Incubator |
B199GDCT37M40 | CT37Stax Incubator |
B199GDCT37M3CO20 | CT37Stax Incubator |
B199GDCT37M30 | CT37Stax Incubator |
B199GDCT37M0 | CT37stax Incubator |