FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PreciseDose Dispenser
DI: 00338779814727
·
Model: 8147-02
·
Medisca Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- PreciseDose Dispenser
- Primary DI
- 00338779814727
- Version / Model
- 8147-02
- Catalog Number
- 8147-02
- Company Name
- Medisca Inc.
- Labeler DUNS
- 794301960
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-05-11
- Public Version
- 1
- Public Version Date
- 2023-05-19
- Public Version Status
- New
- Public Device Record Key
- 072755df-8f0e-4419-86e9-89aad0283eda
- Distribution End Date
- 2023-05-11
Device Description
Syringe, PreciseDose Dispenser Clear, 3mL, w/Tip cap
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYX | Dispenser, Liquid Medication | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64558 | Oral/enteral medicine medicated administration kit, reusable | A collection of devices with an included pharmaceutical intended to be used for the oral and/or enteral administration of an accurate dosage of the included medication. In addition to the pharmaceutical, it will include a dose measuring and/or dispensing device(s) such as a calibrated syringe, medicine cup, or spoon, and may include appropriate accessories (e.g., cap, bottle adaptor). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10338779814724 | GS1 | ||||
| Primary | 00338779814727 | GS1 |