FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Blue PFT Nose Clip with Rubber Pads
DI: 00817081022698
·
Model: Disposable Blue PFT Nose Clip with Rubber Pads - 166700
·
A-M SYSTEMS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Disposable Blue PFT Nose Clip with Rubber Pads
- Primary DI
- 00817081022698
- Version / Model
- Disposable Blue PFT Nose Clip with Rubber Pads - 166700
- Catalog Number
- 166700
- Company Name
- A-M SYSTEMS, LLC
- Labeler DUNS
- 020275145
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-28
- Public Version
- 1
- Public Version Date
- 2019-11-05
- Public Version Status
- New
- Public Device Record Key
- 1dd70a36-26dd-44d7-8dd8-5a23e0f67270
Device Description
Disposable Blue Pulmonary Function Testing Nose Clip with Rubber Pads
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
- Yes
- 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 | 00817081022704 | GS1 | 100 | In Commercial Distribution | ||
| Primary | 00817081022698 | GS1 |
Customer Contacts
- Phone
- 3606838300
- [email protected]