FDA UDI
In Commercial Distribution
🇺🇸 United States
Advocate Lancets Pull Top 30 Gauge
DI: 00894046001066
·
Model: 307
·
DIABETIC SUPPLY OF SUNCOAST, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- Advocate Lancets Pull Top 30 Gauge
- Primary DI
- 00894046001066
- Version / Model
- 307
- Company Name
- DIABETIC SUPPLY OF SUNCOAST, INC.
- Labeler DUNS
- 043081723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-06-22
- Public Version
- 1
- Public Version Date
- 2020-06-30
- Public Version Status
- New
- Public Device Record Key
- afa946e0-f13d-4571-bab0-d2aebbd2c06b
Device Description
Advocate Lancets Pull Top 30 Gauge Box 100, sterile, fine gauge, tri-bevel for obtaining virtually painless capillary blood sample, consistent depth penetration, universal design fits almost all lancing devices, pull off protective cap, discard lancet in puncture-resistant 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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 61579 | Blood lancet, single-use | A sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10894046001063 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00894046001066 | GS1 | ||||
| Unit of Use | 20894046001060 | GS1 |
Customer Contacts
- Phone
- 8884693579
- [email protected]