Duns Number:604208868
Device Description: #1716 Obstetrical KitContains: (2) Underpad 17x24" (2) Umbilical Clamps (1) Umbilical Scis #1716 Obstetrical KitContains: (2) Underpad 17x24" (2) Umbilical Clamps (1) Umbilical Scissors (2) Obstetrical Pad (1) Receiving Blanket (1) Bulb Syringe (4) Towels 3-Ply(1) Emergency Blanket (1) Infant Diaper (2) Nylon Ties (1) Placenta Bag (1) Biohazard Bag (1) Infant Cap (1) Mother/Infant ID Band
Catalog Number
1716
Brand Name
Motion Medical Distributing
Version/Model Number
1716
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
OKV
Product Code Name
Obstetrical Kit
Public Device Record Key
eb072ee9-bf80-4303-9086-47a6c791d9e1
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
25060498450267
Quantity per Package
10
Contains DI Package
15060498450260
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 190 |