FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 10885403076145
·
Model: 4330
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 10885403076145
- Version / Model
- 4330
- Catalog Number
- 4330
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 7
- Public Version Date
- 2023-08-01
- Public Version Status
- Update
- Public Device Record Key
- 5aeb9af0-279a-493f-a922-6f3298acd4d3
- Distribution End Date
- 2025-12-30
Device Description
Manometer, 550 ml Three-Way Stopcock
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KRK | Manometer, blood-pressure, venous | Cardiovascular | 870.1140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31319 | Cerebrospinal fluid manometer, line-powered | A mains electricity (AC-powered) device designed to measure the cerebrospinal fluid (CSF) pressure in a patient using an appropriate pressure/electrical transducer. It is an electronic instrument that connects with a dedicated CSF access device (catheter, cannulae, needle) inserted into the subarachnoid (intrathecal) space of the lumbar section of the spinal column; CSF pressure is typically digitally displayed on a monitor. Connectors, tubing, and CSF access devices are typically included. The device is intended to be used to determine variations in CSF pressure for the purposes of diagnosing, assessing trauma, or to evaluate some other clinical condition (e.g., tumours). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403076143 | GS1 | Case | 5 | In Commercial Distribution | 2025-12-30 |
| Primary | 10885403076145 | GS1 | ||||
| Package | 20885403076142 | GS1 | Box | 10 | In Commercial Distribution | 2025-12-30 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]