Duns Number:825673239
Device Description: AMSafe® 94" (239cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave® Clear, Ro AMSafe® 94" (239cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave® Clear, Rotating Luer, Approx Priming Volume: 57.2mL
Catalog Number
MRSB-94
Brand Name
AMSafe® 94" (239cm) Y-Type Blood Set
Version/Model Number
1
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
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
K983559,K983559
Product Code
FJK
Product Code Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Public Device Record Key
65033c40-ea4e-4f8f-b58a-a6464f9f8d00
Public Version Date
November 19, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
40704411004883
Quantity per Package
25
Contains DI Package
10704411004882
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |