FDA UDI
In Commercial Distribution
🇺🇸 United States
Bongo Rx
DI: 10833224005158
·
Model: BNG515
·
AirAvant Medical
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Bongo Rx
- Primary DI
- 10833224005158
- Version / Model
- BNG515
- Catalog Number
- BNG515
- Company Name
- AirAvant Medical
- Labeler DUNS
- 115178777
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-10
- Public Version
- 1
- Public Version Date
- 2019-04-18
- Public Version Status
- New
- Public Device Record Key
- 774e09a9-fa8f-44c8-8c14-f57db3f09de5
Device Description
Bongo Rx - XL - 1 Pack
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHP | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea | Dental | 872.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11260 | Nasal dilator | A surgical instrument intended to dilate nasal structures/passages during ear/nose/throat (ENT) procedures. It typically consists of a slender and cylindrical body, hollow or solid, made of metal or plastic and available in a variety of sizes and flexibilities. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50833224005156 | GS1 | Master Carton | 32 | In Commercial Distribution | |
| Primary | 10833224005158 | GS1 |
Customer Contacts
- Phone
- 888-925-2526
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180619 | 000 |