Duns Number:105932508
Device Description: Combo Kit: Black and Pink Bling Fanny Pack: Pink Aneroid Sphygmomanometer: 38-402-164 Dual Combo Kit: Black and Pink Bling Fanny Pack: Pink Aneroid Sphygmomanometer: 38-402-164 Dual Head Stethoscope, Deluxe-Lite, Adult, Magenta, Latex Free: 60-840-210-HP 2.5V Standard Otoscope w/specula: 60-402-210-1 Pink Penlight, Tape Measure, Black Taylor Percussion Hammer
Catalog Number
-
Brand Name
BV Medical
Version/Model Number
20-443-164-OTO-L
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
6d81fe4d-e7b8-4c21-9ead-fdd89a3da28e
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
September 24, 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 |