Duns Number:105932508
Device Description: Fanny Pack Nylon Magenta Kit With I Love Nurses On The Front Pouch: 30-510-214-Nurse Gem- Fanny Pack Nylon Magenta Kit With I Love Nurses On The Front Pouch: 30-510-214-Nurse Gem-Scope, Adult, Pink, Latex Free,I love nurses Chest piece: Nurses Pen:Utility Scissors 7.25" (BLACK) With Plastic Probe Tip: 60-460-160 Standard Illumination Penlight, Aluminum, Push Button, Magenta With Batteries : 80-380-000 Fiberglass Tape Measure (White Case): 3D Pedometer: Tracks steps, aerobic steps, distance, calories burned. With 7 day memory and clock: 80-180-SAM Utility Scissors 7.25" (BLACK) With Plastic Probe Tip
Catalog Number
-
Brand Name
BV Medical
Version/Model Number
80-510-164-NursesBP
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
FTY
Product Code Name
Tape, Measuring, Rulers And Calipers
Public Device Record Key
862b1ed4-b7c9-46e1-bfcf-60d50e910fb5
Public Version Date
September 23, 2022
Public Version Number
3
DI Record Publish Date
October 03, 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 |