FDA UDI
In Commercial Distribution
🇺🇸 United States
Resp-O2 PFM Nose Clips, Adult / Pediatric
DI: 00840117322004
·
Model: 36119
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
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Basic Information
- Brand Name
- Resp-O2 PFM Nose Clips, Adult / Pediatric
- Primary DI
- 00840117322004
- Version / Model
- 36119
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2024-10-21
- Public Version
- 2
- Public Version Date
- 2024-10-30
- Public Version Status
- Update
- Public Device Record Key
- 0b3ae113-aa92-471e-bc2e-e218893dd983
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | 00840117321991 | GS1 | Case | 4 | In Commercial Distribution | |
| Primary | 00840117322004 | GS1 | ||||
| Unit of Use | 00810180840682 | GS1 |