Edel Immersys

Basic Information

• Brand Name: Edel Immersys
• Primary DI: 06977066280001
• Version / Model: OVX
• Company Name: Boluo County Longhua Chang Fa Plastic Co.,Ltd
• Labeler DUNS: 527297334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-11
• Public Version: 1
• Public Version Date: 2024-03-19
• Public Version Status: New
• Public Device Record Key: 0d326fa8-6bd6-4a2e-86fe-49a89349e459

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OVX	Water Immersion Labor Pool	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
37074	Birthing bath	A large bath intended to be filled with heated water for use before and/or during child birth. It may be used to deliver the baby under water and/or to provide a comfortable environment for the expecting mother prior to birth. The device may also include specific features such as connectors and diagnostic attachments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06977066280001	GS1