Level 1

GUDID 30610586043448

SMITHS MEDICAL MD, INC.

Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use

• Primary Device ID: 30610586043448
• NIH Device Record Key: 97b2fc70-24ac-46cb-b9db-520c00822b3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Level 1
• Version Model Number: SWU-2016
• Company DUNS: 106712748
• Company Name: SMITHS MEDICAL MD, 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	10610586043444 [Primary]
GS1	30610586043448 [Package]; Contains: 10610586043444; Package: BOX [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: 2022-11-28
• Device Publish Date: 2016-10-11

On-Brand Devices [Level 1]

• 00694393090986: GP-200
• 50695085850005: EQ-5000
• 50695085829506: 8002950
• 50695085829261: H-31-EN
• 50695085828264: H-1100-ES-115V
• 50695085821098: HL-90-40
• 50695085820916: HL-90-SP-115
• 50695085820909: HL-90
• 50695085812904: H-1129
• 50695085800222: 7204018
• 10695085403005: Y-30
• 50695085003630: EQ-5000HF-INT-115V
• 50695085003616: EQ-5000HF-ES-115V
• 50695085003593: EQ-5000HF-EN-115V
• 50695085002930: H-31-ES
• 50695085002657: EQ-5000-INT-115V
• 50695085002404: HL-90-38
• 50695085001872: 8002911
• 50695085001810: EQ-5000-ES-115V
• 50695085000653: SW5-HOSE-7
• 10695085410805: PC-8
• 20695085403804: YC-8
• 30695085401005: L-10
• 30695085400305: SC-3
• 10695085480020: SW-2007
• 10695085460305: IR-6
• 10695085433002: F-30
• 10695085408000: L-80
• 20695085407505: L-70NI
• 10695085403609: X-36
• 20695085403101: Y-INJ
• 20695085402708: L-270
• 10695085002178: SW-2019
• 10695085002161: SW-2018
• 10695085002147: SW-2016
• 10695085002116: SW-2013
• 10695085001782: SW-2011
• 10695085001775: SW-2010
• 20695085001475: C202-3
• 10695085000730: ES100-9
• 10695085000723: SW-2009
• 20695085000614: TTSP-400
• 20695085000607: TTS-400
• 20695085000591: TTSP-TC
• 10695085000587: TTS-TC
• 20695085000577: MTS-40030
• 20695085000560: MTS-40015
• 20695085000553: MTS-4008
• 10695085000549: MTS-TC30
• 20695085000539: MTS-TC15