FDA UDI
In Commercial Distribution
🇺🇸 United States
NATUS ICP LUER CONNECTOR ASSY
DI: 00382830050616
·
Model: NT161057
·
NATUS MEDICAL INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NATUS ICP LUER CONNECTOR ASSY
- Primary DI
- 00382830050616
- Version / Model
- NT161057
- Company Name
- NATUS MEDICAL INCORPORATED
- Labeler DUNS
- 081325959
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-31
- Public Version
- 2
- Public Version Date
- 2025-02-20
- Public Version Status
- Update
- Public Device Record Key
- fda8f792-8ed4-497a-8991-f4a64d8cb878
Device Description
NATUS ICP LUER CONNECTOR ASSY
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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00382830050616 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061568 | 000 |