AMMA 831058
GUDID 00850051245017
Cooler Heads Care, Inc.
Scalp cooling system| Primary Device ID | 00850051245017 |
| NIH Device Record Key | 81ea0aa6-2366-48fa-b864-7d6c21841ea6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMMA |
| Version Model Number | Accessory Kit, Small, 1-pack |
| Catalog Number | 831058 |
| Company DUNS | 116482614 |
| Company Name | Cooler Heads Care, 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com | |
| Phone | 1-619-930-9197 |
| info@coolerheads.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850051245017 [Primary] |
| GS1 | 10850051245014 [Package] Package: Pack [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K211526
FDA Product Code
| PMC | Scalp Cooling System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-01 |
| Device Publish Date | 2023-10-24 |
On-Brand Devices [AMMA]
| 00850051245048 | Starter Kit |
| 00850051245031 | Accessory Kit, Large, 1-pack |
| 00850051245024 | Accessory Kit, Medium, 1-pack |
| 00850051245017 | Accessory Kit, Small, 1-pack |
| 00850051245000 | PSCS |
| 00850051245130 | Accessory Kit, DTC, Large |
| 00850051245123 | Accessory Kit, DTC, Medium |
| 00850051245116 | Accessory Kit, DTC, Small |
Trademark Results [AMMA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMMA 98669161 not registered Live/Pending |
Link, Michelle, R 2024-07-26 |
 AMMA 98632859 not registered Live/Pending |
AMMA Home 2024-07-03 |
 AMMA 97894608 not registered Live/Pending |
UNLMTD Real Estate Group, LLC 2023-04-18 |
 AMMA 97136897 not registered Live/Pending |
Cooler Heads Care, Inc. 2021-11-22 |
 AMMA 90110261 not registered Live/Pending |
Amma Healing, Co. 2020-08-12 |
 AMMA 87678760 5737048 Live/Registered |
American Deposit Management, LLC 2017-11-09 |
 AMMA 86636705 4924388 Dead/Cancelled |
StoneCastle Cash Management LLC 2015-05-20 |
 AMMA 78964245 3398600 Live/Registered |
MATA AMRITANANDAMAYI MATH 2006-08-30 |
 AMMA 78637188 not registered Dead/Abandoned |
Allied Domecq Argentina S.A. 2005-05-25 |
 AMMA 78635050 3231146 Live/Registered |
Bains Ultra Inc. 2005-05-23 |
 AMMA 78227219 2883239 Live/Registered |
MATA AMRITANANDAMAYI MATH 2003-03-19 |
 AMMA 78039416 not registered Dead/Abandoned |
Derian Apparel, LLC 2000-12-15 |
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