Hydrogel Adhesive

GUDID 00865064000195

Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.

VIVALNK, INC.

Waterproof skin adhesive tape

• Primary Device ID: 00865064000195
• NIH Device Record Key: 94a2430d-36ed-43af-b0f5-7ced9c53d4a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydrogel Adhesive
• Version Model Number: A34
• Company DUNS: 013311479
• Company Name: VIVALNK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865064000195 [Primary]

FDA Product Code

• KGX: Tape And Bandage, Adhesive

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: 2022-02-21
• Device Publish Date: 2022-02-11

On-Brand Devices [Hydrogel Adhesive]

• 00865064000188: The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sens
• 00865064000195: Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives
• 00860008259219: Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives
• 00860008259202: Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives
• 00860008259226: Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives