NovaLine

GUDID 16948082770033

Bain Medical Equipment (Guangzhou) Co., Ltd.

Haemodialysis system transducer protector

• Primary Device ID: 16948082770033
• NIH Device Record Key: bc742baf-5a73-45b9-9142-8f2a157afb04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaLine
• Version Model Number: 956007
• Company DUNS: 526972767
• Company Name: Bain Medical Equipment (Guangzhou) Co., Ltd.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06948082770036 [Primary]
GS1	16948082770033 [Package]; Contains: 06948082770036; Package: [60 Units]; In Commercial Distribution
GS1	26948082770030 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240164

FDA Product Code

• FIB: Protector, Transducer, Dialysis

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-08
• Device Publish Date: 2024-07-31

On-Brand Devices [NovaLine]

• 16948082702119: BL 12
• 16948082702102: BL 11
• 16948082709781: BL 43
• 16948082709774: BL 42
• 16948082770033: 956007