Lanhine
GUDID 06971513688181
Zhejiang Lanhine Medical Products Ltd.
Public face mask, single-use| Primary Device ID | 06971513688181 |
| NIH Device Record Key | 40329e88-457f-4849-9754-151fa3696dda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lanhine |
| Version Model Number | 15604F |
| Company DUNS | 543514472 |
| Company Name | Zhejiang Lanhine Medical Products Ltd. |
| Device Count | 50 |
| 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 | false |
Device Dimensions
| Length | 6.9 Inch |
| Width | 3.7 Inch |
| Length | 6.9 Inch |
| Width | 3.7 Inch |
| Length | 6.9 Inch |
| Width | 3.7 Inch |
| Length | 6.9 Inch |
| Width | 3.7 Inch |
| Length | 6.9 Inch |
| Width | 3.7 Inch |
| Length | 6.9 Inch |
| Width | 3.7 Inch |
| Length | 6.9 Inch |
| Width | 3.7 Inch |
| Length | 6.9 Inch |
| Width | 3.7 Inch |
| Length | 6.9 Inch |
| Width | 3.7 Inch |
| Length | 6.9 Inch |
| Width | 3.7 Inch |
| Length | 6.9 Inch |
| Width | 3.7 Inch |
| Length | 6.9 Inch |
| Width | 3.7 Inch |
| Length | 6.9 Inch |
| Width | 3.7 Inch |
| Length | 6.9 Inch |
| Width | 3.7 Inch |
| Length | 6.9 Inch |
| Width | 3.7 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06971513688181 [Unit of Use] |
| GS1 | 06971513688198 [Primary] |
| GS1 | 06971513688204 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K211827
FDA Product Code
| FXX | Mask, Surgical |
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 | 2023-05-04 |
| Device Publish Date | 2023-04-26 |
On-Brand Devices [Lanhine]
| 06971513689515 | 15604F |
| 06971513688150 | 15604F |
| 16971513688171 | 15604F |
| 16971513688164 | 15604F |
| 06971513688181 | 15604F |
Trademark Results [Lanhine]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LANHINE 90156017 not registered Live/Pending |
Zhejiang Lanhine Medical Products Ltd. 2020-09-03 |
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