FDA UDI
In Commercial Distribution
🇺🇸 United States
easycare
DI: 00850015884351
·
Model: 4818-70008
·
Synchronis Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- easycare
- Primary DI
- 00850015884351
- Version / Model
- 4818-70008
- Catalog Number
- 4818-70008
- Company Name
- Synchronis Medical, LLC
- Labeler DUNS
- 080160207
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-07
- Public Version
- 1
- Public Version Date
- 2026-01-15
- Public Version Status
- New
- Public Device Record Key
- 6640081c-7ff0-4531-986a-5e6c9f33ab87
Device Description
Blood Glucose Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65859 | Capillary blood collection set, professional | A collection of devices intended to be used by a healthcare professional at the point-of-care to collect a capillary blood sample from a patient for subsequent diagnostic testing or screening purposes. It typically includes a lancet and a blood collection device (consisting of a capillary tube and blood collection tube) and may also include gloves, gauze pads, alcohol pads and dressings. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850015884368 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 00850015884351 | GS1 |
Customer Contacts
- Phone
- 877.433.9080
- [email protected]