BT37 GDBT37-02-CS

GUDID B199GDBT3702CS0

BT37 Mark 2, Benchtop Incubator

PLANER LIMITED

Assisted reproduction heater/incubator

• Primary Device ID: B199GDBT3702CS0
• NIH Device Record Key: 1d25fb6d-190e-4ef3-9df9-e82c3e814eef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BT37
• Version Model Number: BT37-02
• Catalog Number: GDBT37-02-CS
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B199GDBT3702CS0 [Primary]

FDA Product Code

• PUB: Accessory, Assisted Reproduction, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-09
• Device Publish Date: 2020-07-01

On-Brand Devices [BT37]

• B199GDBT3702WWCS0: BT37 Mark 2, Benchtop Incubator. Worldwide
• B199GDBT3702CS0: BT37 Mark 2, Benchtop Incubator