ONE-CARE PRO Safety Lancets
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Basic Information
- Brand Name
- ONE-CARE PRO Safety Lancets
- Primary DI
- 00810008210659
- Version / Model
- ONE-CARE PRO Safety Lancets, Button-Activated, 28G x 1.5mm
- Catalog Number
- 1012
- Company Name
- MediVena, LLC
- Labeler DUNS
- 080740980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-26
- Public Version
- 1
- Public Version Date
- 2024-03-05
- Public Version Status
- New
- Public Device Record Key
- 3aa9fd77-85be-4640-9229-1e8f111f2d5c
Device Description
MediVena ONE-CARE PRO Push Button Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick prevention mechanism for blood micro-sampling. The product has T-shape main housing and concaved button for stable grip within the hand and easy activation. ONE-CARE PRO Safety Lancets feature long safety tab for convenient twist off and pull out, optimized skin contact area of round shape for convenient placement on the test site. Dual-spring mechanism allows for quick and reliable needle retraction to protect against accidental needlestick injuries. STEP 1 Twist off the safety cap by a full turn of 360 degree, then pull it out, STEP 2 Press the top push button to activate the device, STEP 3 Collect blood sample and dispose the safety lancet into sharps container.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 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 | 00810008211021 | GS1 | case | 20 | In Commercial Distribution | |
| Primary | 00810008210659 | GS1 |
Customer Contacts
- Phone
- 4045142586
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222408 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 28 | Gauge | |
| Length | 1.5 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit