Duns Number:105932508
Device Description: Purple Awareness Nurse Kit: 30-510-234-A Gemscope, Adult, Black tubing, Latex-Free, Purple Purple Awareness Nurse Kit: 30-510-234-A Gemscope, Adult, Black tubing, Latex-Free, Purple Awareness, Two awareness Diaphragms: 60-400-011 High Intensity Otoscope Penlight, Reusable: 60-460-230 Standard Illumination Penlight, Aluminum, Push Button, Purple With Batteries: 3D Pedometer: Tracks steps, aerobic steps, distance, calories burned. With 7 day memory and clock: 8-380J Fiberglass Tape Measure, BV Logo Sticker, White Case: 80-170-210 Utility scissors 5.5", stainless steel with pink handle: 80-174-000 Kelly forceps, 5.5", straight, stainless steel: Nurse Kit Pocket Organizer, White, Latex Free: 80-503-000 Babinski hammer, 8.5"
Catalog Number
-
Brand Name
BV Medical
Version/Model Number
80-510-234-A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ERA
Product Code Name
Otoscope
Public Device Record Key
e55b8a57-5f73-49b0-b2ca-ae89704d0fcd
Public Version Date
September 23, 2022
Public Version Number
6
DI Record Publish Date
October 02, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 658 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 163 |