FreeStyle Freedom 11004
GUDID 30699073110047
FreeStyle Freedom Blood Glucose Monitoring System
ABBOTT DIABETES CARE INC
Glucose/ketone monitoring system IVD, home-use| Primary Device ID | 30699073110047 |
| NIH Device Record Key | 6fbbac48-4492-4cfd-bd9a-5aafd56b259e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FreeStyle Freedom |
| Version Model Number | 11004 |
| Catalog Number | 11004 |
| Company DUNS | 966390890 |
| Company Name | ABBOTT DIABETES 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00699073110046 [Primary] |
| GS1 | 30699073110047 [Package] Contains: 00699073110046 Package: Case [4 Units] In Commercial Distribution |
| NDC/NHRIC | 99073-0110-04 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152442
FDA Product Code
| NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-12 |
Devices Manufactured by ABBOTT DIABETES CARE INC
| 00357599840006 - Libre App | 2024-12-25 Libre Android App US |
| 00357599841003 - Libre App | 2024-12-25 Libre IOS App US |
| 00357599852009 - Lingo | 2024-08-01 Lingo Glucose Biosensor |
| 00357599843007 - FreeStyle Libre 3 Plus | 2024-07-24 FreeStyle Libre 3 PLUS Sensor NFRS |
| 30357599844005 - FreeStyle Libre 3 Plus | 2024-07-24 FreeStyle Libre 3 PLUS Sensor |
| 30357599843008 - FreeStyle Libre 3 Plus | 2024-07-24 FreeStyle Libre 3 PLUS Sensor NFRS |
| 00357599848002 - Lingo | 2024-07-23 Lingo Glucose Biosensor |
| 00357599849009 - Lingo | 2024-07-23 Lingo Biosensor iOS App US |
Trademark Results [FreeStyle Freedom]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FREESTYLE FREEDOM 78574141 3169832 Dead/Cancelled |
ABBOTT DIABETES CARE INC. 2005-02-24 |
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