FDA UDI
In Commercial Distribution
🇺🇸 United States
NEUTRACLEAR BIDIRECTIONAL VALVE WITH PROTECTIVE CAP
DI: 13661657080940
·
Model: NC100C
·
CAIR LGL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NEUTRACLEAR BIDIRECTIONAL VALVE WITH PROTECTIVE CAP
- Primary DI
- 13661657080940
- Version / Model
- NC100C
- Company Name
- CAIR LGL
- Labeler DUNS
- 380834713
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-01
- Public Version
- 1
- Public Version Date
- 2026-01-09
- Public Version Status
- New
- Public Device Record Key
- 289ec325-3a89-42b5-999e-444a9ac98eee
Device Description
NEUTRACLEAR BIDIRECTIONAL VALVE WITH PROTECTIVE CAP
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
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42750 | Neutral-pressure intravenous line needleless valve-connector | A small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point there is minimal fluid flow into or out of the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 23661657080947 | GS1 | Carton box | 200 | In Commercial Distribution | |
| Primary | 13661657080940 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171117 | 000 |