FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 30885632127636
·
Model: UD9005
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 30885632127636
- Version / Model
- UD9005
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-28
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 03222c6c-984e-4e5d-8f5f-fbd16dd9b3f5
Device Description
Solution Respiratory 9 Percent Sodium Chloride Convenient Twist-Off Cap 5 Milliliter Sterile Not Made With Natural Rubber Latex MediChoice
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 |
|---|---|---|---|---|
| CAF | NEBULIZER (DIRECT PATIENT INTERFACE) | Anesthesiology | 868.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58499 | Inhalation therapy saline solution, hypertonic | A sterile, hypertonic saline solution, consisting only of water and sodium chloride (> 0.9% NaCl) intended to be used for the induction of sputum in a patient, via physiological osmotic mechanisms, especially indicated for palliative treatment of cystic fibrosis (CF). It is intended to be used with a nebulizer to produce a mist that can be inhaled into the lungs where cells lining the airways are triggered to release water and facilitate restoration of the layer of moisture lining the airways for clearing of mucous. The solution is typically available in a single unit-of-use container. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885632127630 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 30885632127636 | GS1 | ||||
| Unit of Use | 10885632127632 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K820227 | 000 |