FDA UDI
In Commercial Distribution
🇺🇸 United States
ZValves
DI: 00833224009029
·
Model: ZV902
·
Project Snore
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- ZValves
- Primary DI
- 00833224009029
- Version / Model
- ZV902
- Catalog Number
- ZV902
- Company Name
- Project Snore
- Labeler DUNS
- 144946937
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2026-02-20
- Public Version
- 1
- Public Version Date
- 2026-03-02
- Public Version Status
- New
- Public Device Record Key
- 1b694e57-6c4f-4789-9dfc-258d2523f550
Device Description
ZValves - SM - 3 Pack
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| LWF | Dilator, Nasal | Ear, Nose, Throat | 874.3900 | 1 |
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 |
|---|---|---|---|---|---|---|
| Primary | 00833224009029 | GS1 | ||||
| Unit of Use | 90833224009022 | GS1 |
Customer Contacts
- Phone
- 888-828-4321
- [email protected]