FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OneTouch SureSoft
DI: 00353885006842
·
Model: 021-141
·
LifeScan Europe GmbH
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
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Basic Information
- Brand Name
- OneTouch SureSoft
- Primary DI
- 00353885006842
- Version / Model
- 021-141
- Company Name
- LifeScan Europe GmbH
- Labeler DUNS
- 480240820
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-02-03
- Public Version
- 3
- Public Version Date
- 2025-12-05
- Public Version Status
- Update
- Public Device Record Key
- c43fc9c7-bf40-46b1-8cbc-3e3bf2e94abc
- Distribution End Date
- 2025-12-04
Device Description
One Touch SureSoft Single Use Disposable Lancing Device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMK | Lancet, Blood | General, Plastic Surgery | 878.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61578 | Manual blood lancing device, single-use | A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20353885006846 | GS1 | 40 | Not in Commercial Distribution | 2025-12-04 | |
| Primary | 00353885006842 | GS1 | ||||
| Secondary | 53885-141-10 | NDC/NHRIC | ||||
| Unit of Use | 80353885006824 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 18 | Gauge |