Duns Number:604208868
Device Description: #1727 Obstetrical KitContains:1 pr. Gloves L/F2 ea. Umbilical Clamps1 ea. Umbilical Scisso #1727 Obstetrical KitContains:1 pr. Gloves L/F2 ea. Umbilical Clamps1 ea. Umbilical Scissor (N/S)1 ea. Receiving Blanket2 ea. Sponge 4x41 ea. Bulb Syringe3 ea. Towels 1 ea. Underpad 17x24"2 ea. OB Towelettes1 ea. OB Pad1 ea. Bib Apron2 ea. Twist Ties2 ea. Nylon Ties1 ea. Placenta Bag
Catalog Number
1727
Brand Name
Motion Medical Distributing
Version/Model Number
1727
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
e960921d-f471-485e-972b-c932a1a1a0c0
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
25060498450298
Quantity per Package
10
Contains DI Package
15060498450291
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 |