| Primary Device ID | 00812120002754 |
| NIH Device Record Key | 93c32de2-73fe-4bb1-9f27-0ec8bfc26d25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Med4 Elite |
| Version Model Number | 650500-EN09 |
| 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 | 00812120002754 [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 |