Solar GI air-charged 4P, Compact Pole system

GUDID 08720648846007

Solar GI air-charged 4P, Compact Pole system, 115V

Medical Measurement Systems B.V.

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• Primary Device ID: 08720648846007
• NIH Device Record Key: 6a6f9e0b-96d9-42da-9e72-346625d0a2e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solar GI air-charged 4P, Compact Pole system
• Version Model Number: G3-7 Air
• Company DUNS: 416277333
• Company Name: Medical Measurement Systems B.V.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08720648846007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121014

FDA Product Code

• FFX: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

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: 2022-05-16
• Device Publish Date: 2022-05-07

Devices Manufactured by Medical Measurement Systems B.V.

• 08717775955702 - HEM: 2022-11-28
• 08717775955870 - HEM FS: 2022-11-28
• 08720648846007 - Solar GI air-charged 4P, Compact Pole system: 2022-05-16Solar GI air-charged 4P, Compact Pole system, 115V
• 08720648846007 - Solar GI air-charged 4P, Compact Pole system: 2022-05-16 Solar GI air-charged 4P, Compact Pole system, 115V
• 08717775953012 - Impedance/pH, 6 imp channels, 1 pH antimony, Adult, 6.4 Fr: 2020-10-19
• 08717775953036 - Impedance/pH, 6 imp channels, 2 pH antimony, Gastric+oes pH, Adult: 2020-10-19 Adult, 6.4 Fr
• 08717775953067 - Impedance/pH, 6 imp channels, 1 pH antimony, Pediatric, 6.4 Fr: 2020-10-19
• 08717775953104 - Impedance/pH, 6 imp channels, 1 pH antimony, Infant, 1.5 cm spacing: 2020-10-19 6.4 Fr
• 08717775954071 - Impedance/pH, 6 imp channels, 1 pH antimony, LES locator: 2020-10-19 Adult, 6.9 Fr