FDA UDI
In Commercial Distribution
🇺🇸 United States
M9227, Nose Clip
DI: 06420099000677
·
Model: M9227
·
Medikro Oy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- M9227, Nose Clip
- Primary DI
- 06420099000677
- Version / Model
- M9227
- Company Name
- Medikro Oy
- Labeler DUNS
- 369263660
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-07-13
- Public Version
- 1
- Public Version Date
- 2018-08-13
- Public Version Status
- New
- Public Device Record Key
- e77d712c-5dca-459a-9897-3c9c10d3d309
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
- No
- 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 |
|---|---|---|---|---|
| BXJ | Clip, Nose | Anesthesiology | 868.6225 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10907 | Nose clip, single-use | A device intended to be used to compress the nose externally, to ensure that airflow is exclusively conducted through the mouth during examinations of the pulmonary function (e.g., spirometry), and/or to stop nosebleeds (epistaxis). It is typically constructed of plastic with rubber or foam tips. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06420099000677 | GS1 | ||||
| Unit of Use | 06420099001025 | GS1 |