BT37 Incubator

GUDID B199GDBT37WWORIGIO0

BT37 Benchtop Incubator

PLANER LIMITED

Assisted reproduction heater/incubator Assisted reproduction heater/incubator

• Primary Device ID: B199GDBT37WWORIGIO0
• NIH Device Record Key: 7154de3d-827d-4268-bb42-4469732a1055
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BT37 Incubator
• Version Model Number: GDBT37-WW-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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Recharge every 4 months by connecting to the mains power supply for 24 hours
• Special Storage Condition, Specify: Between 0 and 0 *Recharge every 4 months by connecting to the mains power supply for 24 hours
• Special Storage Condition, Specify: Between 0 and 0 *Recharge every 4 months by connecting to the mains power supply for 24 hours
• Special Storage Condition, Specify: Between 0 and 0 *Recharge every 4 months by connecting to the mains power supply for 24 hours
• Special Storage Condition, Specify: Between 0 and 0 *Recharge every 4 months by connecting to the mains power supply for 24 hours
• Special Storage Condition, Specify: Between 0 and 0 *Recharge every 4 months by connecting to the mains power supply for 24 hours
• Special Storage Condition, Specify: Between 0 and 0 *Recharge every 4 months by connecting to the mains power supply for 24 hours
• Special Storage Condition, Specify: Between 0 and 0 *Recharge every 4 months by connecting to the mains power supply for 24 hours
• Special Storage Condition, Specify: Between 0 and 0 *Recharge every 4 months by connecting to the mains power supply for 24 hours
• Special Storage Condition, Specify: Between 0 and 0 *Recharge every 4 months by connecting to the mains power supply for 24 hours

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B199GDBT37WWORIGIO0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121566

FDA Product Code

• MQG: Accessory, Assisted Reproduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-28
• Device Publish Date: 2016-09-23

On-Brand Devices [BT37 Incubator ]

• B199GDBT37WWORIGIO0: BT37 Benchtop Incubator
• B199GDBT37USORIGIO0: BT37 Benchtop Incubator.
• B199GDBT3701ORIGIO0: BT37 Benchtop Incubator - Origio