FDA UDI
In Commercial Distribution
🇺🇸 United States
Wedge Pressure 6fr 80cm Modified J-tip
DI: M82216280P2
·
Model: 162-80P
·
ALPHA MEDICAL INSTRUMENTS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Wedge Pressure 6fr 80cm Modified J-tip
- Primary DI
- M82216280P2
- Version / Model
- 162-80P
- Catalog Number
- 162-80P
- Company Name
- ALPHA MEDICAL INSTRUMENTS
- Labeler DUNS
- 627767577
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-08
- Public Version
- 6
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- b10e2117-6079-40f8-a0c3-7a354b93e8e7
Device Description
Wedge Pressure Balloon Catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | 870.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35889 | Pulmonary artery balloon catheter, non-electrical | A flexible, non-electrical tube with an inflatable balloon at its distal tip designed to be introduced percutaneously into the venous system via a central vein (e.g., jugular, subclavian), and advanced from the superior vena cava to the pulmonary artery, to measure/monitor a haematological parameter(s) [e.g., pulmonary arterial pressures (e.g., wedge), stroke volume] via the pressure changes at its distal tip. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., external blood pressure transducer) and may include devices dedicated to introduction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M82216280P2 | HIBCC |
Customer Contacts
- Phone
- 949-460-0944
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K920873 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 77 Degrees Fahrenheit