CompressAR Large SuperComfort Disc 150-0303-06

GUDID 10815614020231

The CompressAR Large SuperComfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compression to the femoral artery during hemostasis. The Model 5303 is a large sized round disc with upturned edges and an elastomeric center (2" dia.).

SEMLER TECHNOLOGIES, INC.

Femoral artery compression system, manual, single-use

• Primary Device ID: 10815614020231
• NIH Device Record Key: 02fa85ab-45fb-433c-a70a-23a77c17fe8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompressAR Large SuperComfort Disc
• Version Model Number: 5303
• Catalog Number: 150-0303-06
• 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	10815614020231 [Primary]
GS1	20815614020238 [Package]; Package: Box [12 Units]; In Commercial Distribution
GS1	30815614020235 [Package]; Contains: 20815614020238; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040615

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

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