FDA UDI
In Commercial Distribution
🇺🇸 United States
ONE-CARE PLUS Safety Lancets
DI: 00810008210222
·
Model: 1006 ONE-CARE PLUS Safety Lancets 21G / 2.8mm, MaxFlow, Orange, 100/bx, 20bx/cs
·
MediVena, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- ONE-CARE PLUS Safety Lancets
- Primary DI
- 00810008210222
- Version / Model
- 1006 ONE-CARE PLUS Safety Lancets 21G / 2.8mm, MaxFlow, Orange, 100/bx, 20bx/cs
- Catalog Number
- 1006
- Company Name
- MediVena, LLC
- Labeler DUNS
- 080740980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-16
- Public Version
- 1
- Public Version Date
- 2025-02-24
- Public Version Status
- New
- Public Device Record Key
- c93beb9e-91ac-4ce8-aa4e-c5f135f87e73
Device Description
Contact-activated ONE-CARE PLUS Safety Lancets 21G x 2.8 mm are designed with an ergonomic body for a comfortable grip, ensuring ease of use during procedures. The reliable safety activation mechanism guarantees consistent performance, while the wide cap allows for easy twist-off, facilitating straightforward preparation for use. This innovative design provides an optimal combination of safety, comfort, and convenience.
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 | 00810008210307 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00810008210222 | GS1 |
Customer Contacts
- Phone
- 4045142586
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222408 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 21 | Gauge | |
| Length | 2.8 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit