ClampEase Disc 150-2022-24

GUDID 10815614020309

The ClampEase FAPD-RT Disc is a femoral artery round tunnel pressure disc with a TAPER attach.

SEMLER TECHNOLOGIES, INC.

Femoral artery compression system, manual, single-use

• Primary Device ID: 10815614020309
• NIH Device Record Key: b119490c-0e42-4816-9105-bfad1f0bfbca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClampEase Disc
• Version Model Number: FAPD-RT
• Catalog Number: 150-2022-24
• Company DUNS: 042075700
• Company Name: SEMLER TECHNOLOGIES, 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	10815614020309 [Primary]
GS1	20815614020306 [Package]; Package: Bag [24 Units]; In Commercial Distribution
GS1	30815614020303 [Package]; Contains: 20815614020306; Package: Case [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964663

FDA Product Code

• DXC: Clamp, Vascular

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: 2023-07-04
• Device Publish Date: 2016-09-24

On-Brand Devices [ClampEase Disc]

• 20815614021020: The ClampEase FAPD-OT Disc is a femoral artery oval tunnel pressure disc with a TAPER attach.
• 20815614021037: The ClampEase FAPD-RT Disc is a femoral artery round tunnel pressure disc with a TAPER attach.
• 10815614021016: The ClampEase FAPD-RB Disc is a femoral artery round tunnel pressure disc with a BALL attach.
• 20815614021006: The ClampEase FAPD-FB Disc is a femoral artery flat tunnel pressure disc with a BALL attach.
• 10815614020309: The ClampEase FAPD-RT Disc is a femoral artery round tunnel pressure disc with a TAPER attach.
• 10815614020293: The ClampEase FAPD-OT Disc is a femoral artery oval tunnel pressure disc with a TAPER attach.
• 10815614020279: The ClampEase FAPD-RB Disc is a femoral artery round tunnel pressure disc with a BALL attach.
• 10815614020255: The ClampEase FAPD-FB Disc is a femoral artery flat tunnel pressure disc with a BALL attach.