Primary Device ID | 00850044855308 |
NIH Device Record Key | 51718c25-7d81-442c-bf3b-e0de8dcb801f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OWELL |
Version Model Number | OWSL30G1.5MM-100 |
Company DUNS | 123151704 |
Company Name | OWELL |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850044855308 [Primary] |
FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-14 |
Device Publish Date | 2025-08-06 |
00850044855025 | OWELL Lancing Device With Ejector |
00850044855339 | OWELL Safety Lancets | 21g - 2.5mm | 100ct |
00850044855322 | OWELL Safety Lancets | 23g - 2.2mm | 100ct |
00850044855315 | OWELL Safety Lancets | 26g - 1.8mm | 100ct |
00850044855308 | OWELL Safety Lancets | 30g - 1.5mm | 100ct |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() OWELL 97581305 not registered Live/Pending |
Alcove Brands LLC 2022-09-07 |
![]() OWELL 87921119 5642646 Live/Registered |
Guangzhoushi Junkuai Dianzishangwuyouxiangongsi 2018-05-15 |
![]() OWELL 73067948 1065760 Dead/Cancelled |
Casutt; Toni 1975-11-03 |