9Line R-8675309

GUDID G0960R86753095

Disposable SafeDwell Foley Catheter Monitor with Securement BX of 25

Rising Eagle Medical LLC

Urinary catheter holder

• Primary Device ID: G0960R86753095
• NIH Device Record Key: 160e5715-26a7-4cf2-8feb-786f9687f8be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 9Line
• Version Model Number: R-8675309
• Catalog Number: R-8675309
• Company DUNS: 080145608
• Company Name: Rising Eagle Medical LLC
• 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: 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
HIBCC	G0960R86753090 [Primary]
HIBCC	G0960R86753095 [Package]; Contains: G0960R86753090; Package: Box [25 Units]; In Commercial Distribution

FDA Product Code

• EYJ: Holder, Ureteral Catheter

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: 2024-02-07
• Device Publish Date: 2024-01-30

On-Brand Devices [9Line]

• G096NK6SS0505: 6 Lead, Snap, SPU Shielded ECG Leadwires,50in, NK Comp, AAMI, 50/BX
• G096NK6SS0305: 6 Lead, Snap, SPU Shielded ECG Leadwires, 30in, NK Comp, AAMI, 50/BX
• G096NK6PS0505: 6 Lead, Pinch, SPU Shielded ECG Leadwires,50in, NK Comp, AAMI, 50/BX
• G096NK6PS0305: 6 Lead, Pinch, SPU Shielded ECG Leadwires, 30in, NK Comp, AAMI, 50/BX
• G096NK3SS0505: 3 Lead, Snap, SPU Shielded ECG Leadwires,50in, NK Comp, AAMI, 50/BX
• G096NK3SS0305: 3 Lead, Snap, SPU Shielded ECG Leadwires, 30in, NK Comp, AAMI, 50/BX
• G096NK3PS0505: 3 Lead, Pinch, SPU Shielded ECG Leadwires,50in, NK Comp, AAMI, 50/BX
• G096NK3PS0305: 3 Lead, Pinch, SPU Shielded ECG Leadwires, 30in, NK Comp, AAMI, 50/BX
• G0965VSS0505: 5V Leads, Snap, SPU Shielded ECG Leadwires,50in, Philips Comp, AAMI, 50/BX
• G0965VSS0305: 5V Leads, Snap, SPU Shielded ECG Leadwires, 30in, Philips Comp, AAMI, 50/BX
• G0965VPS0505: 5V Leads, Pinch, SPU Shielded ECG Leadwires,50in, Philips Comp, AAMI, 50/BX
• G0965VPS0305: 5V Leads, Pinch, SPU Shielded ECG Leadwires, 30in, Philips Comp, AAMI, 50/BX
• G0965SS0505: 5 Lead, Snap, SPU Shielded ECG Leadwires,50in, Philips Comp, AAMI, 50/BX
• G0965SS0305: 5 Lead, Snap, SPU Shielded ECG Leadwires, 30in, Philips Comp, AAMI, 50/BX
• G0965PS0505: 5 Lead, Pinch, SPU Shielded ECG Leadwires,50in, Philips Comp, AAMI, 50/BX
• G0965PS0305: 5 Lead, Pinch, SPU Shielded ECG Leadwires, 30in, Philips Comp, AAMI, 50/BX
• G0963SS0500: 3 Lead, Snap, SPU Shielded ECG Leadwires,50in, Philips Comp, AAMI, 50/BX
• G0963SS0300: 3 Lead, Snap, SPU Shielded ECG Leadwires, 30in, Philips Comp, AAMI, 50/BX
• G0963PS0505: 3 Lead, Pinch, SPU Shielded ECG Leadwires,50in, Philips Comp, AAMI, 50/BX
• G0963PS0305: 3 Lead, Pinch, SPU Shielded ECG Leadwires, 30in, Philips Comp, AAMI, 50/BX
• G096PS5VSS0365: 5V Leads, Snap, SPU Shielded ECG Leadwires, 36in, Philips/Spacelabs Comp, AAMI, 50/BX
• G096PS5SS0365: 5 Lead, Snap, SPU Shielded ECG Leadwires, 36in, Philips/Spacelabs Comp, AAMI, 50/BX
• G096PS5PS0365: 5 Lead, Pinch, SPU Shielded ECG Leadwires, 36in, Philips/Spacelabs Comp, AAMI, 50/BX
• G096PS3SS0365: 3 Lead, Snap, SPU Shielded ECG Leadwires, 36in, Philips/Spacelabs Comp, AAMI, 50/BX
• G096PS3PS0365: 3 Lead, Pinch, SPU Shielded ECG Leadwires, 36in, Philips/Spacelabs Comp, AAMI, 50/BX
• G096NK6SS0365: 6 Lead, Snap, SPU Shielded ECG Leadwires, 36in, NK Comp, AAMI, 50/BX
• G096NK6PS0365: 6 Lead, Pinch, SPU Shielded ECG Leadwires, 36in, NK Comp, AAMI, 50/BX
• G096NK3SS0365: 3 Lead, Snap, SPU Shielded ECG Leadwires,36in, NK Comp, AAMI, 50/BX
• G096NK3PS0365: 3 Lead, Pinch SPU Shielded ECG Leadwires,36in, NK Comp, AAMI, 50/BX
• G096GE5VPS0365: 5V Leads, Pinch, SPU Shielded ECG Leadwires, 36in, GE Comp, AAMI, 50/BX
• G096GE5PS0365: 5 Lead, Pinch, SPU Shielded ECG Leadwires, 36in, GE Comp, AAMI, 50/BX
• G096GE3PS0365: 3 Lead, Pinch, SPU Shielded ECG Leadwires, 36in, GE Comp, AAMI, 50/BX
• G096DR5PS0365: 5 Lead, Pinch, SPU Shielded ECG Leadwires, 36in, Draeger Comp, AAMI, 50/BX
• G0965VPS0365: 5V Leads, Pinch, SPU Shielded ECG Leadwires, 36in, Philips/Spacelabs Comp, AAMI, 50/BX
• G096R929225: Disposable CardiPatch, skin patch over pacemaker site cushion (1 Case of 6 boxes. Each box conta
• G0960R86753095: Disposable SafeDwell Foley Catheter Monitor with Securement BX of 25
• G096PS5VSS0505: 5V Leads, Snap, SPU Shielded ECG Leadwires, 50in, Philips/Spacelabs Comp, AAMI, 50/BX
• G096PS5VPS0505: 5V Leads, Pinch, SPU Shielded ECG Leadwires, 50in, Philips/Spacelabs Comp, AAMI, 50/BX
• G096PS5SS0505: 5 Lead, Snap, SPU Shielded ECG Leadwires, 50in, Philips/Spacelabs Comp, AAMI, 50/BX
• G096PS5PS0505: 5 Lead, Pinch, SPU Shielded ECG Leadwires, 50in, Philips/Spacelabs Comp, AAMI, 50/BX
• G096PS3SS0505: 3 Lead, Snap, SPU Shielded ECG Leadwires, 50in, Philips/Spacelabs Comp, AAMI, 50/BX
• G096PS3PS0500: 3 Lead, Pinch, SPU Shielded ECG Leadwires, 50in, Philips/Spacelabs Comp, AAMI, 50/BX
• G096GE5VPS0505: 5V Leads, Pinch, SPU Shielded ECG Leadwires, 36in, GE Comp, AAMI, 50/BX
• G096GE5PS0505: 5 Lead, Pinch, SPU Shielded ECG Leadwires, 50in, GE Comp, AAMI, 50/BX
• G096GE3PS0500: 3 Lead, Pinch, SPU Shielded ECG Leadwires, 50in, GE Comp, AAMI, 50/BX
• G096DR5PS0505: 5 Lead, Pinch, SPU Shielded ECG Leadwires, 50in, Draeger Comp, AAMI, 50/BX