FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TopCare health
DI: 00036800281738
·
Model: 036800281738
·
TOPCO ASSOCIATES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
Basic Information
- Brand Name
- TopCare health
- Primary DI
- 00036800281738
- Version / Model
- 036800281738
- Company Name
- TOPCO ASSOCIATES, LLC
- Labeler DUNS
- 072943876
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2020-07-13
- Public Version
- 2
- Public Version Date
- 2022-08-03
- Public Version Status
- Update
- Public Device Record Key
- 6a26ef63-6dcc-43c4-8277-3c3e3eb164f5
- Distribution End Date
- 2021-12-08
Device Description
Drug Free Nasal Strips, Large, Clear Strips
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LWF | Dilator, Nasal | Ear, Nose, Throat | 874.3900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47606 | Nasal breathing aid, external | An external device intended to improve breathing by decreasing nasal resistance, thus increasing nasal airflow. The device typically consists of an adhesive bandage with two parallel elastic strips placed on the bridge of the nose; it acts with an upward pulling force to flare the nostrils and open the nares. It provides temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or nasal congestion. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00036800413313 | GS1 | case | 36 | Not in Commercial Distribution | 2021-12-08 |
| Primary | 00036800281738 | GS1 | ||||
| Unit of Use | 60036800281730 | GS1 |
Customer Contacts
- Phone
- 18884230139
- [email protected]