Level 1

GUDID 30610586043370

Smiths Medical ASD, Inc.

Circulating-air whole-body heating/cooling system pad, single-use

• Primary Device ID: 30610586043370
• NIH Device Record Key: eb4afa95-ff93-406c-941d-7d3f27c63999
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Level 1
• Version Model Number: SWU-2008
• Company DUNS: 082005361
• Company Name: Smiths Medical ASD, 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: true
• 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	10610586043376 [Primary]
GS1	30610586043370 [Package]; Contains: 10610586043376; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141686

FDA Product Code

• DWJ: System, thermal regulating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-04-03
• Device Publish Date: 2016-10-11

On-Brand Devices [Level 1]

• 10695085410003: D-100
• 30695085470308: IR-7
• 50695085470203: PL-7
• 50695085460204: PL-6
• 20695085407000: L-70
• 10695085404002: IR-40
• 20695085470103: IR-700
• 10695085430001: D-300
• 10695085406006: D-60HL
• 15019517121551: L1-CW-120V
• 15019517100457: L1-PWR-B
• 15019517100297: L1-Cart
• 15019517100280: L1-Hose
• 15019517100273: L1-Shelf
• 15019517061833: Urine Meter Foley Tray with Temperature
• 15019517061826: Urine Meter Foley Tray with Temperature
• 30695085002813: L-370
• 15019517100303: L1-FILTER
• 15019517042474: F3-5000
• 30610586043370: SWU-2008