DigniCap® Delta 800-2002
GUDID 00850036106173
DeltaKit 2 (Mesh bag includes Cooling Wrap, Chin Strap, Wet Brush, Spray Bottle, Headband, & Patient Guide)
Dignitana AB
Scalp cooling system| Primary Device ID | 00850036106173 |
| NIH Device Record Key | 8fed1416-eac7-48fe-af15-40b10c27f860 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DigniCap® Delta |
| Version Model Number | 800-2002 |
| Catalog Number | 800-2002 |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 |
Customer Support Contacts
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850036106173 [Primary] |
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 | 2022-02-10 |
| Device Publish Date | 2022-02-02 |
On-Brand Devices [DigniCap® Delta]
| 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 |
Trademark Results [DigniCap]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIGNICAP 79136729 4578099 Live/Registered |
Dignitana AB 2013-08-22 |
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