| Primary Device ID | 00850036106272 | 
| NIH Device Record Key | ff2ee684-67ee-41cb-87a1-8974950811dd | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | DigniCap® Delta | 
| Version Model Number | 700-1003 | 
| Catalog Number | 700-1003 | 
| Company DUNS | 775901619 | 
| Company Name | Dignitana AB | 
| 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 | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | |
| Phone | 877-375-8070 | 
| info@dignitana.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00850036106272 [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 | 2022-02-08 | 
| Device Publish Date | 2022-01-31 | 
| 00850036106272 | Drain Hose | 
| 00850036106265 | Installation Hose | 
| 00850036106258 | Therapy Hose | 
| 00850036106302 | Power Cord UK, 16A/ 250V, C19, 3M | 
| 00850036106296 | Power Cord EU, 16A/ 250V, C19, 3M | 
| 00850036106289 | Power Cord US, 15A/125V, C19, 3M | 
| 00850036106210 | Cooling Wrap, Small Size, SPU, 1-ct | 
| 00850036106197 | Cooling Wrap, Standard Size, SPU, 1-ct | 
| 00850036106159 | DeltaCool US - DeltaCool, DCD, 10 pk Domestic (case of 10) Coolant bottled and shipped within th | 
| 00850036106333 | Thermal Cap, Universal Size, SPU, Qty 10 | 
| 00850036106326 | Cooling Wrap, Small Size, SPU, Qty 10 | 
| 00850036106319 | Cooling Wrap, Standard Size, SPU, Qty 10 | 
| 00850036106234 | Thermal Cap, Universal Size, SPU, 1-ct | 
| 00850036106180 | DeltaKit 3 - DeltaKit 3 (Mesh bag includes Cooling Wrap, Chin Strap, Headband, & Patient Guide) | 
| 00850036106173 | DeltaKit 2 (Mesh bag includes Cooling Wrap, Chin Strap, Wet Brush, Spray Bottle, Headband, & Pat | 
| 00850036106166 | DeltaKit 1 (Mesh bag includes Cooling Wrap, Thermal Cap, Chin Strap, Wet Brush, Spray Bottle, He | 
| 00850036106074 | 1-ct Single-Use DeltaCard, DCD | 
| 00850036106036 | Connection Kit, US, DCD-01 | 
| 00850036106005 | DigniCap Delta System | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  DIGNICAP  79136729  4578099 Live/Registered | Dignitana AB 2013-08-22 |