Primary Device ID | 20353885013004 |
NIH Device Record Key | 41d38192-ce21-420b-a854-e58822952023 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OneTouch Ultra |
Version Model Number | 024-391 |
Company DUNS | 153409313 |
Company Name | LIFESCAN, INC. |
Device Count | 30 |
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 |
Special Storage Condition, Specify | Between 0 and 0 *do not refrigerate |
Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *do not refrigerate |
Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *do not refrigerate |
Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *do not refrigerate |
Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *do not refrigerate |
Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *do not refrigerate |
Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *do not refrigerate |
Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *do not refrigerate |
Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *do not refrigerate |
Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *do not refrigerate |
Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *do not refrigerate |
Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *do not refrigerate |
Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00353885013000 [Primary] |
GS1 | 20353885013004 [Package] Contains: 00353885013000 Package: [24 Units] In Commercial Distribution |
GS1 | 80353885013006 [Unit of Use] |
NBW | System, Test, Blood Glucose, Over The Counter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-30 |
Device Publish Date | 2025-06-20 |
20353885013004 - OneTouch Ultra | 2025-06-30 |
20353885013004 - OneTouch Ultra | 2025-06-30 |
20353885012656 - OneTouch Ultra Blue Test Strips | 2022-08-05 OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch U |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ONETOUCH ULTRA 77223516 3491332 Live/Registered |
Johnson & Johnson 2007-07-06 |
![]() ONETOUCH ULTRA 76661414 3436618 Dead/Cancelled |
JOHNSON & JOHNSON 2006-06-12 |
![]() ONETOUCH ULTRA 76661413 3462824 Dead/Cancelled |
JOHNSON & JOHNSON 2006-06-12 |