FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CODMAN HAKIM HOLTER
DI: 10886704045748
·
Model: NS0512
·
Cerenovus, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CODMAN HAKIM HOLTER
- Primary DI
- 10886704045748
- Version / Model
- NS0512
- Catalog Number
- NS0512
- Company Name
- Cerenovus, Inc.
- Labeler DUNS
- 607846297
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-20
- Public Version
- 6
- Public Version Date
- 2023-09-15
- Public Version Status
- Update
- Public Device Record Key
- 1bbf3189-aa16-4a5d-a9d6-1b39ad3a1d9f
- Distribution End Date
- 2022-09-01
Device Description
CODMAN HAKIM Precision Fixed Pressure Valve with Proximal Tubing and .060 Inch Platform Operating Pressure: 100mm H2O Medium High Range Includes: HOLTER Type "B" Connector, Straight Connector, Priming Adapter and information Manual
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
- 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 |
|---|---|---|---|---|
| JXG | Shunt, central nervous system and components | Neurology | 882.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35965 | Cerebrospinal fluid shunt valve | An implantable device intended to function as part of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the lumbar spine or brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of synthetic polymer and/or metallic materials; it does not incorporate a port or reservoir. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10886704045748 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053350 | 000 |