Duns Number:604208868
Device Description: #1719 Obstetrical KitContents: (1) Umbilical Scissor, (2) Umbilical Clamp, (1) Bulb Syring #1719 Obstetrical KitContents: (1) Umbilical Scissor, (2) Umbilical Clamp, (1) Bulb Syringe, (1) Underpad 17x24, (1) Receiving Blanket, (2) Towel 3-Ply, (2) Sponge 4x4 2/Pk, (1) OB Pad, (2) Glove L/F Pair, (2) OB Towelette, (1) Apron, (1) Infant Diaper, (1) Bunting Bunting, (2) Twist Tie, (1) Placenta Bag
Catalog Number
1719
Brand Name
Motion Medical Distributing
Version/Model Number
1719
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
b5e1757d-351c-44b0-ad6f-e621ac76cc30
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
January 31, 2017
Package DI Number
25060498450274
Quantity per Package
10
Contains DI Package
15060498450277
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 190 |