Duns Number:105932508
Device Description: Combo Kit: Frosted Blue Fanny Pack: 38-416-344 Sprague Rappaport-Type, Adult, Frosted Blue Combo Kit: Frosted Blue Fanny Pack: 38-416-344 Sprague Rappaport-Type, Adult, Frosted Blue, Latex Free Aneroid Sphygmomanometer, 60-664-000 Kawe Diagnostic penlight, white metal with push-button , 8-380J Fiberglass Tape Measure, BV Logo Sticker, White Case: 80-170-150 Utility scissors 5.5", stainless steel with light blue handle: 80-500-999 Taylor Percussion Hammer, Stealth
Catalog Number
-
Brand Name
BV Medical
Version/Model Number
20-443-344-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
03bdc4c2-8ec8-43eb-9f5d-077f96aa6d38
Public Version Date
September 23, 2022
Public Version Number
4
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 |