FDA UDI
In Commercial Distribution
🇺🇸 United States
Blood Specimen Collection Kit (EPH)
DI: 00810121520000
·
Model: Exempt
·
Quest Diagnostics
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Blood Specimen Collection Kit (EPH)
- Primary DI
- 00810121520000
- Version / Model
- Exempt
- Company Name
- Quest Diagnostics
- Labeler DUNS
- 189222334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-23
- Public Version
- 1
- Public Version Date
- 2023-08-31
- Public Version Status
- New
- Public Device Record Key
- ede165ee-34c1-4212-8c0d-bba5ead7077d
Device Description
The Tasso+ Kit is a kit that includes the Tasso+ device and all supplies necessary to collect a blood sample. The Tasso+ device is a sterile, disposable blood lancing device. When collecting a sample, the device is held onto the skin by a mild adhesive. A sterile lancet punctures the skin with a press of the button, simultaneously this creates a slight vacuum that helps capillary blood flow under gravity into a compatible tube. After a predefined time period, or when the tube is full, the device is peeled off the skin. The tube is removed and capped for transport. The lancet is single use and automatically retracts into the device in a safe position after use.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KST | System, Blood Collection, Vacuum-Assisted, Manual | Hematology | 864.9125 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37243 | Manual blood lancing device, reusable | A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810121520000 | GS1 |