FDA UDI
In Commercial Distribution
🇺🇸 United States
Centurion
DI: 20653160288333
·
Model: CLPH2O001-5
·
CENTURION MEDICAL PRODUCTS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Centurion
- Primary DI
- 20653160288333
- Version / Model
- CLPH2O001-5
- Company Name
- CENTURION MEDICAL PRODUCTS CORPORATION
- Labeler DUNS
- 017246562
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-10
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b3652c4f-0559-493c-85ec-039a58ee4b4f
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 |
|---|---|---|---|---|
| 61537 | Cerebrospinal fluid manometer, battery-powered | A sterile, noninvasive, battery-powered device designed to measure the cerebrospinal fluid (CSF) pressure/intracranial pressure via lumbar puncture. It is a small housing with an integrated transducer and pressure display intended to be connected to separate invasive CSF access devices (e.g., catheter, cannula, needle) which are inserted into the subarachnoid (intrathecal) space of the lumbar region of the spinal column. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00653160288339 | GS1 | BOX | 5 | In Commercial Distribution | |
| Primary | 20653160288333 | GS1 | ||||
| Package | 10653160288336 | GS1 | CASE | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)248-4058
- [email protected]