Fetal Doppler

GUDID 00866755000289

HATCH BABY, INC.

Foetal Doppler system

• Primary Device ID: 00866755000289
• NIH Device Record Key: d4d222df-4caf-4ed6-a0cc-9d32f931c653
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fetal Doppler
• Version Model Number: HBL 16001WHT
• Company DUNS: 942892345
• Company Name: HATCH BABY, INC.
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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
GS1	00866755000289 [Primary]
GS1	10866755000286 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• KNG: Monitor, Ultrasonic, Fetal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-15