FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 40612479199659
·
Model: 1150
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- McKesson
- Primary DI
- 40612479199659
- Version / Model
- 1150
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-09
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- db04c24a-1b7b-4100-98cc-3fcf3f2c91d0
Device Description
DOPPLER SYSTEM, ABI/AVS
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
- No
- 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 |
|---|---|---|---|---|
| JAF | Monitor, Ultrasonic, Nonfetal | Radiology | 892.1540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58928 | Noninvasive ankle brachial pressure index measurement unit | An automated, battery-powered, portable electronic device designed to calculate the ankle brachial pressure index (ABPI), used in the diagnosis of peripheral vascular disease (PVD), from simultaneous oscillometric measurement of the ankle and brachial blood pressure indices. It typically consists of a control/analysis/display unit with cuffs placed around an arm and one or both ankles; it uses integrated transducers to measure cuff pressure oscillations which represent the fluctuations of pressure in the underlying blood vessels. The device is typically operated by a healthcare professional. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 40612479199659 | GS1 | ||||
| Direct Marking | 10612479214146 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063600 | 000 |