FDA UDI
In Commercial Distribution
🇺🇸 United States
Muc-Away™
DI: 10889483230121
·
Model: 0489
·
SUNMED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Muc-Away™
- Primary DI
- 10889483230121
- Version / Model
- 0489
- Catalog Number
- 0489
- Company Name
- SUNMED, LLC
- Labeler DUNS
- 069009268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-31
- Public Version
- 1
- Public Version Date
- 2026-01-08
- Public Version Status
- New
- Public Device Record Key
- 7362572d-7c71-4bb7-8d9b-04ce73388c4f
Device Description
Muc-Away™, Comfort Soft Plus™, 4.5" Nasal Aspiration Device "Mini Muc™"
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
- Yes
- 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 |
|---|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41826 | Nasal aspirator, manual | A portable, hand-held, manual suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It is available in a variety of forms including a compressible bulb with a tube that is inserted into the nares, or a syringe with a small bulb at its distal end that is applied to the nasal opening. It is designed for domestic use. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10889483230121 | GS1 | ||||
| Package | 20889483230128 | GS1 | Box | 40 | In Commercial Distribution | |
| Previous | 00709078005312 | GS1 |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]