Edel Immersys

GUDID 06977066280001

Boluo County Longhua Chang Fa Plastic Co.,Ltd

Birthing bath

• Primary Device ID: 06977066280001
• NIH Device Record Key: 0d326fa8-6bd6-4a2e-86fe-49a89349e459
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edel Immersys
• Version Model Number: OVX
• Company DUNS: 527297334
• Company Name: Boluo County Longhua Chang Fa Plastic Co.,Ltd
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• 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	06977066280001 [Primary]

FDA Product Code

• OVX: Water Immersion Labor Pool

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: 2024-03-19
• Device Publish Date: 2024-03-11