FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Transonic
DI: 08774660001449
·
Model: H12AUL-5
·
TRANSONIC SYSTEMS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Transonic
- Primary DI
- 08774660001449
- Version / Model
- H12AUL-5
- Company Name
- TRANSONIC SYSTEMS INC.
- Labeler DUNS
- 101317451
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-28
- Public Version
- 4
- Public Version Date
- 2021-11-05
- Public Version Status
- Update
- Public Device Record Key
- ae46911c-4107-43f1-9a2d-aff7c339d9be
- Distribution End Date
- 2021-10-01
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | Cardiovascular | 870.2100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61227 | Invasive vascular ultrasound system | A mains electricity (AC-powered) device assembly designed to invasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) using ultrasound/Doppler/transit time technology during procedures involving vascular surgery. It may also provide additional measurements (e.g., blood pressure, vascular resistance). It consists of a mobile (on wheels) control unit with graphical user-interface, typically placed outside the sterile field; and an attached, reusable, sterilizable probe intended to be used within the body (invasive) but not within the lumen of the blood vessel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08774660001449 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K872048 | 000 |