FDA UDI
In Commercial Distribution
🇺🇸 United States
Centurion
DI: 20653160288357
·
Model: CTHR002-5
·
CENTURION MEDICAL PRODUCTS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Centurion
- Primary DI
- 20653160288357
- Version / Model
- CTHR002-5
- Company Name
- CENTURION MEDICAL PRODUCTS CORPORATION
- Labeler DUNS
- 017246562
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-07
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 0e3e8741-4036-4656-912d-b1ac3b285890
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DRS | TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR | Cardiovascular | 870.2850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61538 | Pleural manometer | A sterile, noninvasive, battery-powered device intended to convert pressure into electrical signals for the measurement of pressure within the pleural cavity. It is a small housing with an integrated transducer and pressure display intended to be connected to a separate invasive vascular access device (e.g., needle, pleural catheter). It may be used to measure lung elasticity during thoracentesis. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10653160288350 | GS1 | CASE | 5 | In Commercial Distribution | |
| Primary | 20653160288357 | GS1 | ||||
| Package | 00653160288353 | GS1 | BOX | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)248-4058
- [email protected]