Duns Number:825673239
Device Description: CANISTER ATTACHMENT BRACKET FOR RECEPTAL™ ACCU-MEASURE® DEVICE FOR USE WITH 1000ML, 1500ML CANISTER ATTACHMENT BRACKET FOR RECEPTAL™ ACCU-MEASURE® DEVICE FOR USE WITH 1000ML, 1500ML AND 2000ML CANISTERS
Catalog Number
433050420
Brand Name
CANISTER ATTACHMENT BRACKET FOR RECEPTAL™ ACCU-MEASURE® DEVICE
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
bfeef90c-652b-4d2d-9c84-92eba43de396
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
40704411000724
Quantity per Package
10
Contains DI Package
10704411000723
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 |