ClampEase U-View Disc 150-2012-50a

GUDID 20815614021068

The ClampEase U-View U-OS003 Disc is a femoral artery medium oval slotted pressure disc with a TAPER attach.

SEMLER TECHNOLOGIES, INC.

Vascular compressor, external

• Primary Device ID: 20815614021068
• NIH Device Record Key: 59b77e73-c737-4bf2-83ac-0abc29f42c46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClampEase U-View Disc
• Version Model Number: U-OS003
• Catalog Number: 150-2012-50a
• 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: true
• 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	10815614021061 [Primary]
GS1	20815614021068 [Package]; Contains: 10815614021061; Package: Bag [25 Units]; In Commercial Distribution
GS1	30815614021065 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-09
• Device Publish Date: 2022-09-01

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