FDA UDI
In Commercial Distribution
🇺🇸 United States
SonaStar
DI: 00841626100299
·
Model: E0702ABC07
·
MISONIX, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SonaStar
- Primary DI
- 00841626100299
- Version / Model
- E0702ABC07
- Company Name
- MISONIX, INC.
- Labeler DUNS
- 065963449
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 4
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- f227d601-4b55-41e8-83d5-9e1022ae5f6e
Device Description
SonaStar I.V. Pole
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36069 | Freestanding/bed-attached intravenous pole | A freestanding or equipment-attached metal rod with two or more hooked bars extending horizontally from its top from which various fluid delivery devices (bags or bottles) can be suspended for the administration of intravenous (IV) fluids/medication to the patient. It is used during infusion therapy for intravenous administration of fluids/solutions or blood transfusions. Infusion pumps and/or syringe pumps can also be attached to it. Also called an IV pole or drip pole, it can be a fixed or side-swinging, adjustable, vertical pole attached to a bed, operating table, wheelchair, or more commonly, an independent floor-standing IV pole for bedside use; some have wheels for patient mobility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841626100299 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062471 | 000 |