| Primary Device ID | 00812120002877 | 
| NIH Device Record Key | a4d32ec1-fff8-4976-8341-e17b7e5d2fd2 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Med4 Elite | 
| Version Model Number | 650500-EN07 | 
| Company DUNS | 840831411 | 
| Company Name | GAME READY DIVISION | 
| 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 | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00812120002877 [Primary] | 
| ILO | Pack, Hot Or Cold, Water Circulating | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2018-01-24 | 
| 00812120002945 | Med4 Elite Control Unit, Demo | 
| 00812120002921 | System, Med4 Elite, EU, Spanish | 
| 00812120002877 | System, Med4 Elite, Brazil, English | 
| 00812120002860 | System, Med4 Elite, Switzerland, Italian | 
| 00812120002853 | System, Med4 Elite, Switzerland, German | 
| 00812120002846 | System, Med4 Elite, Italy, Spanish | 
| 00812120002839 | System, Med4 Elite, EU, German | 
| 00812120002822 | System, Med4 Elite, EU, French | 
| 00812120002815 | System, Med4 Elite, North America, French | 
| 00812120002808 | System, Med4 Elite, North America, Spanish | 
| 00812120002785 | System, Med4 Elite, Japan, Japanese | 
| 00812120002761 | System, Med4 Elite, Denmark, English | 
| 00812120002754 | System, Med4 Elite, Australia, English | 
| 00812120002747 | System, Med4 Elite, Argentina, Spanish | 
| 00812120002730 | System, Med4 Elite, Brazil, Spanish | 
| 00812120002723 | System, Med4 Elite, Switzerland, French | 
| 00812120002716 | System, Med4 Elite, India, English | 
| 00812120002709 | System, Med4 Elite, Italy, Italian | 
| 00812120002693 | System, Med4 Elite, UK, English | 
| 00812120002686 | System, Med4 Elite, EU, English | 
| 00812120002679 | System, Med4 Elite, North America, English | 
| 00812120002617 | Power Cord, Med4 Elite, KSC 8305 KOREAN | 
| 00812120002600 | Power Cord, Med4 Elite, JIS 8303 JAPAN | 
| 00812120002594 | Power Cord, Med4 Elite, SI 32 Israeli | 
| 00812120002587 | Power Cord, Med4 Elite, SRAF 1962/DB 16/87 DANISH | 
| 00812120002570 | Power Cord, Med4 Elite, AS/NZS 4417 15A | 
| 00812120002563 | Power Cord, Med4 Elite, IRAM 2073:2009 Argentina | 
| 00812120002556 | Power Cord, Med4 Elite, NBR 14136 Brazil | 
| 00812120002549 | Power Cord, Med4 Elite, SEV 1011 Swiss | 
| 00812120002532 | Power Cord, Med4 Elite, IS 6538 India | 
| 00812120002525 | Power Cord, Med4 Elite, CEI 23-16 Italian | 
| 00812120002518 | Power Cord, Med4 Elite, BS 1363 UK13, United Kingdom | 
| 00812120002501 | Power Cord, Med4 Elite, CEE 7/7 Schuko, European Union | 
| 00812120002495 | Power Cord, Med4 Elite, NEMA 5-15P, North America | 
| 00812120002211 | Med4 Elite Control Unit | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  MED4 ELITE  86688960  5470017 Live/Registered | CoolSystems, Inc. 2015-07-09 |