KENTEC EXTENSION SET

GUDID 10810080610436

MPS Pharma & Medical, Inc.

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• Primary Device ID: 10810080610436
• NIH Device Record Key: 59e2d0de-1297-4081-82ef-bbb0acd297a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KENTEC EXTENSION SET
• Version Model Number: KMI483C
• Company DUNS: 117970217
• Company Name: MPS Pharma & Medical, Inc.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810080610439 [Primary]
GS1	10810080610436 [Package]; Contains: 00810080610439; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955896

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

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: 2022-09-01
• Device Publish Date: 2022-08-24

On-Brand Devices [KENTEC EXTENSION SET]

• 10810080610450: KMI959
• 10810080610443: KMI636
• 10810080610436: KMI483C
• 10810080610429: KMI467C