Duns Number:105932508
Device Description: Combo Kit: Purple Fanny Pack: 38-416-234 Sprague Rappaport-Type, Adult, Purple, Latex Free Combo Kit: Purple Fanny Pack: 38-416-234 Sprague Rappaport-Type, Adult, Purple, Latex Free: 20-208-234-L Classic Aneroid Sphygmomanometer, Purple Nylon Cuff, Adult, Latex Free: 60-403-020 Penlight, Reusable, With Pupil Gauge, Chrome: 80-153-000 Lister bandage scissors, with clip, stainless steel, 5.5 ": 80-380-000 Fiberglass Tape Measure (White Case).
Catalog Number
-
Brand Name
BV Medical
Version/Model Number
20-481-234-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
6352be48-528c-4f9d-8d7c-06f4b9e0ea33
Public Version Date
September 23, 2022
Public Version Number
3
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 |