Single Lead High Volume Pump Chamber Set

GUDID 00816513022657

MPS MEDICAL, INC

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• Primary Device ID: 00816513022657
• NIH Device Record Key: 042e9fd5-3dbb-4737-99a0-c3bf9407f375
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Lead High Volume Pump Chamber Set
• Version Model Number: G82721-M
• Company DUNS: 079636164
• Company Name: MPS 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816513022657 [Primary]
GS1	10816513022654 [Package]; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K850757

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-25
• Device Publish Date: 2017-05-10

On-Brand Devices [Single Lead High Volume Pump Chamber Set]

• 00816513022657: G82721-M
• 00816513022640: G82711-M
• 10816513023569: G827331-M
• 10816513023460: G82721-MF