FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CODMAN
DI: 10886704066446
·
Model: NS5060A
·
Cerenovus, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CODMAN
- Primary DI
- 10886704066446
- Version / Model
- NS5060A
- Catalog Number
- NS5060A
- 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
- 7
- Public Version Date
- 2023-09-15
- Public Version Status
- Update
- Public Device Record Key
- bfc96f2b-20a1-49b9-9d8b-6610460bc0cd
- Distribution End Date
- 2022-09-01
Device Description
CODMAN Lumbar Luer-Lok Assembly Plastic Cap and Luer with a Stainless Steel Barbed Connector End Includes: 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
- MR Conditional
- 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 |
|---|---|---|---|---|
| 61118 | Cerebrospinal fluid catheter tubing set | A two-way tubing with a stopcock designed to connect the proximal end of a cerebrospinal fluid (CSF) drainage catheter directly to a drainage bag or an intracranial pressure monitor via a Luer connection. It is typically made of polymer materials [e.g., polyvinyl chloride (PVC)] and profiled at both ends to create leak-proof connections. It may also feature a tap-like valve to isolate the line when injecting, flushing, or replacing the drainage bag. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20886704066443 | GS1 | Package | 3 | Not in Commercial Distribution | 2022-09-01 |
| Primary | 10886704066446 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K910938 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away From Sunlight