BT37 Incubator

GUDID B199GDBT3701ORIGIO0

BT37 Benchtop Incubator - Origio

PLANER LIMITED

Assisted reproduction heater/incubator

• Primary Device ID: B199GDBT3701ORIGIO0
• NIH Device Record Key: aaf217e0-2db5-47f2-b1c1-879f03651d57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BT37 Incubator
• Version Model Number: GDBT37-01-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

• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B199GDBT3701ORIGIO0 [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