FDA UDI
In Commercial Distribution
🇺🇸 United States
ReddyPort
DI: 00850001175227
·
Model: RP-MKITQ4-2
·
SMD Manufacturing LLC
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ReddyPort
- Primary DI
- 00850001175227
- Version / Model
- RP-MKITQ4-2
- Company Name
- SMD Manufacturing LLC
- Labeler DUNS
- 070849038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-12
- Public Version
- 1
- Public Version Date
- 2023-07-20
- Public Version Status
- New
- Public Device Record Key
- d54461e7-ed19-4c3c-ada4-8e0e4b732c3e
Device Description
ReddyPort 24-hour NIV Maintenance Kit follows Q4 protocols (every 4 hours) for standard oral care procedures.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | 880.6025 | 1 |
| JOL | Catheter And Tip, Suction | General Hospital | 880.6740 | 2 |
| EFW | Toothbrush, Manual | Dental | 872.6855 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66090 | Cannulated manual toothbrush | A non-powered instrument designed to be used by a healthcare provider/caregiver to manually brush clean the teeth and gums of a disabled/geriatric patient while simultaneously removing excess oral fluid (saliva, toothpaste). It consists of a proximal handle with a distal bristle head and an integrated suction cannula. It is intended to be used in conjunction with a suction pump (not included). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850001175224 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00850001175227 | GS1 |
Customer Contacts
- Phone
- +1 (801) 899-3036
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Room Temperature