| Primary Device ID | 00851682007562 |
| NIH Device Record Key | a3a46337-8e98-4871-a96d-3358397bff11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cooler Heads |
| Version Model Number | 830771 |
| Company DUNS | 080312381 |
| Company Name | PATHWAY, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Serial Number | true |
| 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 | 00851682007562 [Primary] |
| PMC | Scalp Cooling System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-15 |
| Device Publish Date | 2022-11-07 |
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| 00850041415147 - ClearTract | 2024-05-29 2-Way 100% Silicone, 16Fr X 5ml, ClearTract SPT Catheter |
| 00850041415154 - ClearTract | 2024-05-29 2-Way 100% Silicone, 16Fr X 10ml, ClearTract SPT Catheter |
| 00850041415161 - ClearTract | 2024-05-29 2-Way 100% Silicone, 18Fr X 10ml, ClearTract SPT Catheter |
| 00860009140509 - UpLyft | 2023-08-16 Patient Transfer System |
| 00851682007562 - Cooler Heads | 2022-11-15AMMA Portable Scalp Cooling System |
| 00851682007562 - Cooler Heads | 2022-11-15 AMMA Portable Scalp Cooling System |
| 20851682007009 - Kurin Blood Collection Set, 21 Ga, BioMerieux | 2019-10-23 |
| 20851682007016 - Kurin Blood Collection Set, 23 Ga, BD BioMerieux | 2019-10-23 |