FDA UDI
In Commercial Distribution
🇺🇸 United States
LEADER
DI: 00096295145106
·
Model: 5966312
·
Cardinal Health 110, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- LEADER
- Primary DI
- 00096295145106
- Version / Model
- 5966312
- Catalog Number
- 5966312
- Company Name
- Cardinal Health 110, Inc.
- Labeler DUNS
- 063997360
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-15
- Public Version
- 1
- Public Version Date
- 2025-07-23
- Public Version Status
- New
- Public Device Record Key
- e22fb450-29ac-4195-bc5c-7986a0268609
Device Description
LDR Nebulizer System All-in-One 1 count
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAF | Nebulizer (direct patient interface) | Anesthesiology | 868.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62042 | Nebulizing system delivery set, reusable | A collection of non-sterile devices intended to be connected to a nebulizer system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patients respiratory system. It typically includes flexible tubing with connectors, a mask or mouthpiece, and a nebulizing medication chamber; pharmaceuticals are not included. This is a single-patient, reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50096295145101 | GS1 | CASE | 4 | In Commercial Distribution | |
| Primary | 00096295145106 | GS1 |
Customer Contacts
- Phone
- +1(800)200-6313
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K043238 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity