FDA UDI
In Commercial Distribution
🇺🇸 United States
Biotronix Healthcare
DI: 00850005165071
·
Model: RE-343002U
·
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Biotronix Healthcare
- Primary DI
- 00850005165071
- Version / Model
- RE-343002U
- Catalog Number
- RE-343002U
- Company Name
- BIOTRONIX HEALTHCARE INDUSTRIES, INC.
- Labeler DUNS
- 065762392
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-04
- Public Version
- 2
- Public Version Date
- 2019-12-24
- Public Version Status
- Update
- Public Device Record Key
- 415fde67-2e7e-4a0d-9e18-7adf35b9b4ad
Device Description
Nebulizer with Elongated Adult Mask, 7ft. No Crush Tubing and Universal Connector
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 31309 | Nebulizing system delivery set, single-use | A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850005165078 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00850005165071 | GS1 |
Customer Contacts
- Phone
- 786-473-9436
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140237 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Nebulizer with Elongated Adult Mask, 7ft. No Crush Tubing and Universal Connector |