Duns Number:118492643
Device Description: FRESH WHOLE BLOODDONOR SETConstricting Band (18”x1”) 1 ea FRESH WHOLE BLOODDONOR SETConstricting Band (18”x1”) 1 ea Alcohol Pads 2 eaGauze Sponge 2 ea Chlorhexidine Swab 1 eaBlood Tube- Lavender Top 4 ea Kelly Clamp 1 eaBlood Tube- Red Top 2 ea Nylon Cord (10”) 1 eaBlood Collection Needle 1 ea Beaded Cable Tie 1 eaSurgical Tape 1 ea Permanent Marker 1 eaClear IV Dressing 1 ea ASBP 572 1 eaABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 eaBlood Collection Bag 1 ea Instructions for Use 1 eaGloves (Pair) 1 ea
Catalog Number
80-801-D
Brand Name
Fresh Whole Blood Donor Transfusion Set
Version/Model Number
11
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PDQ
Product Code Name
Neurosurgical Nerve Locator
Public Device Record Key
6ef66480-03b7-4192-b2e0-5d52401c9743
Public Version Date
August 17, 2022
Public Version Number
1
DI Record Publish Date
August 09, 2022
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |