MICROLET®NEXT 85267299
GUDID 40301936705013
Lancing Device
ASCENSIA DIABETES CARE US INC.
Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable| Primary Device ID | 40301936705013 |
| NIH Device Record Key | 0a99a5ea-20a1-42be-951b-cde7ba4809a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MICROLET®NEXT |
| Version Model Number | 6705 |
| Catalog Number | 85267299 |
| Company DUNS | 080028910 |
| Company Name | ASCENSIA DIABETES CARE US INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00301936705015 [Primary] |
| GS1 | 40301936705013 [Package] Contains: 00301936705015 Package: shipper/case [100 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220633
FDA Product Code
| FMK | Lancet, Blood |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only |
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 | 2019-06-14 |
| Device Publish Date | 2019-06-06 |
On-Brand Devices [MICROLET®NEXT]
| 40301936721013 | Alternative Site Testing (AST) Endcap |
| 40301936705013 | Lancing Device |
| 40301936702012 | Lancing Device. 1 Kit: 1 MICROLET®NEXT lancing device with adjustable endcap; 5 MICROLET® ste |
Trademark Results [MICROLET]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MICROLET 88151546 not registered Live/Pending |
Ascensia Diabetes Care Holdings AG 2018-10-11 |
 MICROLET 75069425 2100253 Dead/Cancelled |
BAYER CORPORATION 1996-03-08 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.