Infusion Set for Single Use

GUDID 06970440020248

Shinva Ande Healthcare Apparatus Co., Ltd

Infusion controller administration set

• Primary Device ID: 06970440020248
• NIH Device Record Key: 7e8dfca1-a50f-4f91-a5b8-62d8853ce00e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infusion Set for Single Use
• Version Model Number: AD0401
• Company DUNS: 421062164
• Company Name: Shinva Ande Healthcare Apparatus 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: 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	06970440020071 [Primary]
GS1	06970440020231 [Package]; Contains: 06970440020071; Package: [40 Units]; In Commercial Distribution
GS1	06970440020248 [Package]; Contains: 06970440020071; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162601

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

[06970440020248]

Ethylene Oxide

[06970440020248]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-15

On-Brand Devices [Infusion Set for Single Use]

• 06970440020309: AD0502
• 06970440020286: AD0501
• 06970440020262: AD0402
• 06970440020248: AD0401
• 06970440020224: AD0302
• 06970440020200: AD0301
• 06970440020187: AD0202
• 06970440020163: AD0201
• 06970440020149: AD0102
• 06970440020019: AD0101