ClampEase U-View Disc 150-2022-52a

GUDID 20815614021051

The ClampEase U-View U-SRS200 Disc is a femoral artery small round slotted pressure disc with a TAPER attach.

SEMLER TECHNOLOGIES, INC.

Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use

• Primary Device ID: 20815614021051
• NIH Device Record Key: 1ff6bb2e-97ec-4e21-8803-16828b8bda3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClampEase U-View Disc
• Version Model Number: U-SRS200
• Catalog Number: 150-2022-52a
• 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	10815614021054 [Primary]
GS1	20815614021051 [Package]; Contains: 10815614021054; Package: Bag [25 Units]; In Commercial Distribution
GS1	30815614021058 [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