Primary Device ID | 18809445831991 |
NIH Device Record Key | c2bdd663-d8b8-4656-91b3-398328067a61 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | WellFine® |
Version Model Number | WellFine®Insulin Pen Needles 33Gx5mm 100pcs |
Company DUNS | 689719789 |
Company Name | MEDEXEL CO.,LTD. |
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 | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +82312991077 |
parkhj@medexel.co.kr |
Needle Gauge | 33 Gauge |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08809445831994 [Primary] |
GS1 | 18809445831991 [Package] Contains: 08809445831994 Package: case [12 Units] In Commercial Distribution |
GS1 | 28809445831998 [Package] Package: Master case [6 Units] In Commercial Distribution |
FMI | Needle, Hypodermic, Single Lumen |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-10-23 |
Device Publish Date | 2019-02-23 |
18809445832011 | Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct |
18809445832004 | Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct |
18809445831991 | Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct |
18809445831984 | Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct |
18809445831977 | Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct |
18809445831960 | Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct |
18809445831953 | Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct |
18809445831946 | Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct |
18809445831939 | Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct |
18809445831922 | Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct |
18809445831915 | Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct |
18809445831908 | Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunct |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
WELLFINE 97708087 not registered Live/Pending |
Shenzhen Hongjing Electronics Co., Ltd. 2022-12-07 |
WELLFINE 90741618 not registered Live/Pending |
Shenzhen Hongjing Electronics Co., Ltd. 2021-05-28 |
WELLFINE 90741601 not registered Live/Pending |
Shenzhen Hongjing Electronics Co., Ltd. 2021-05-28 |
WELLFINE 90741535 not registered Live/Pending |
Shenzhen Hongjing Electronics Co., Ltd. 2021-05-28 |