FDA UDI In Commercial Distribution 🇺🇸 United States

Polytech Noseclip

DI: B446N100753S1 · Model: N100753S · POLYTECHNIC RESOURCES INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100

Basic Information

Brand Name
Polytech Noseclip
Primary DI
B446N100753S1
Version / Model
N100753S
Company Name
POLYTECHNIC RESOURCES INC
Labeler DUNS
825021079
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2020-12-18
Public Version
1
Public Version Date
2020-12-28
Public Version Status
New
Public Device Record Key
43230cd6-5d0e-4d32-9482-ed94afa20aa0

Device Description

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.

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
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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
BXJ Clip, Nose

GMDN Terms

Code Name
10907 Nose clip, single-use

Identifiers

Type ID
Unit of Use B446N100753S0
Primary B446N100753S1