xinle XLB2822
GUDID 16950383616194
LANCET PURPLE 28G X 2.2MM
Hebei Xinle Sci&Tech Co., Ltd.
Manual blood lancing device, single-use| Primary Device ID | 16950383616194 |
| NIH Device Record Key | fc84bb7d-43b4-4b7a-9959-e8c6a119c81d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | xinle |
| Version Model Number | XL-B 28G |
| Catalog Number | XLB2822 |
| Company DUNS | 529813593 |
| Company Name | Hebei Xinle Sci&Tech Co., Ltd. |
| Device Count | 100 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Device Dimensions
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06950383616197 [Primary] |
| GS1 | 16950383616194 [Package] Contains: 06950383616197 Package: Carton [50 Units] In Commercial Distribution |
| GS1 | 86950383616193 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221839
FDA Product Code
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-22 |
| Device Publish Date | 2023-09-14 |
On-Brand Devices [xinle]
| 16950383616361 | LANCET GRAY 30G X 2.4MM |
| 16950383616354 | LANCET GRAY 30G X 2.2MM |
| 16950383616347 | LANCET GRAY 30G X 2.0MM |
| 16950383616330 | LANCET GRAY 30G X 1.8MM |
| 16950383616323 | LANCET PURPLE 28G X 2.4MM |
| 16950383616316 | LANCET PURPLE 28G X 2.2MM |
| 16950383616309 | LANCET PURPLE 28G X 2.0MM |
| 16950383616293 | LANCET PURPLE 28G X 1.8MM |
| 16950383616286 | LANCET GREEN 21G X 2.4MM |
| 16950383616279 | LANCET GREEN 21G X 2.2MM |
| 16950383616262 | LANCET GREEN 21G X 2.0MM |
| 16950383616255 | LANCET GREEN 21G X 1.8MM |
| 16950383616248 | LANCET GRAY 30G X 2.4MM |
| 16950383616231 | LANCET GRAY 30G X 2.2MM |
| 16950383616224 | LANCET GRAY 30G X 2.0MM |
| 16950383616217 | LANCET GRAY 30G X 1.8MM |
| 16950383616200 | LANCET PURPLE 28G X 2.4MM |
| 16950383616194 | LANCET PURPLE 28G X 2.2MM |
| 16950383616187 | LANCET PURPLE 28G X 2.0MM |
| 16950383616170 | LANCET PURPLE 28G X 1.8MM |
| 16950383616163 | LANCET GREEN 21G X 2.4MM |
| 16950383616156 | LANCET GREEN 21G X 2.2MM |
| 16950383616149 | LANCET GREEN 21G X 2.0MM |
| 86950383616131 | LANCET GREEN 21G X 1.8MM |
Trademark Results [xinle]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XINLE 97615379 not registered Live/Pending |
Ganzhou Lingze New Trade Co., Ltd. 2022-09-30 |
 XINLE 90740856 not registered Live/Pending |
Xia, Leping 2021-05-28 |
 XINLE 79348923 not registered Live/Pending |
Hebei Xinle Medical Device Technology Co., Ltd. 2022-06-29 |
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