ClampEase U-View Disc 150-2022-51

GUDID 10815614020316

The ClampEase U-View U-LRS100 Disc is a femoral artery large round slotted pressure disc with a TAPER attach.

SEMLER TECHNOLOGIES, INC.

Femoral artery compression system, manual, single-use

• Primary Device ID: 10815614020316
• NIH Device Record Key: 70a551a5-25c3-4a84-9765-f245763f44f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClampEase U-View Disc
• Version Model Number: U-LRS100
• Catalog Number: 150-2022-51
• 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	10815614020316 [Primary]
GS1	20815614020313 [Package]; Package: Bag [25 Units]; In Commercial Distribution
GS1	30815614020310 [Package]; 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: 6
• Public Version Date: 2023-07-04
• Device Publish Date: 2016-09-24

On-Brand Devices [ClampEase U-View Disc]

• 20815614021075: The ClampEase U-View U-LRS100 Disc is a femoral artery large round slotted pressure disc with a
• 20815614021068: The ClampEase U-View U-OS003 Disc is a femoral artery medium oval slotted pressure disc with a T
• 20815614021051: The ClampEase U-View U-SRS200 Disc is a femoral artery small round slotted pressure disc with a
• 10815614020330: The ClampEase U-View U-OS003 Disc is a femoral artery medium oval slotted pressure disc with a T
• 10815614020323: The ClampEase U-View U-SRS200 Disc is a femoral artery small round slotted pressure disc with a
• 10815614020316: The ClampEase U-View U-LRS100 Disc is a femoral artery large round slotted pressure disc with a