Primary Device ID | B199GDBT37USORIGIO0 |
NIH Device Record Key | f55a5b13-1658-49a2-875f-f1b4b5cda08d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BT37 Incubator |
Version Model Number | GDBT37-US-ORIGIO |
Company DUNS | 217190495 |
Company Name | PLANER LIMITED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | true |
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 |
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 | B199GDBT37USORIGIO0 [Primary] |
MQG | Accessory, Assisted Reproduction |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-10-28 |
Device Publish Date | 2016-09-23 |
B199GDBT37WWORIGIO0 | BT37 Benchtop Incubator |
B199GDBT37USORIGIO0 | BT37 Benchtop Incubator. |
B199GDBT3701ORIGIO0 | BT37 Benchtop Incubator - Origio |