Duns Number:604208868
Device Description: Obstetrical KitContents: (2) Gloves L/F, (2) Umbilical Clamps, (1) Umbilical Scissor, (1) Obstetrical KitContents: (2) Gloves L/F, (2) Umbilical Clamps, (1) Umbilical Scissor, (1) Receiving Blanket, (2) Sponge 4x4, (1) Bulb Syringe, (2) Towels 3-Ply, (1) Underpad 17x24, (2) Obstetrical Towelettes, (1) Obstetrical Pad, (1) Infant Diaper, (2) Twist Ties, (2) Nylon Ties, (1) Placenta Disposal Bag
Catalog Number
1709
Brand Name
Motion Medical Distributing
Version/Model Number
1709
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
8cf35d0d-69c7-47df-8dce-00bf0e938279
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
October 11, 2016
Package DI Number
25060498450243
Quantity per Package
10
Contains DI Package
15060498450246
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 |