Duns Number:604208868
Device Description: #1737 Obstetrical KitContents: (1) Glove L/F Pair, (1) Underpad 17x24, (2) Umbilical Clamp #1737 Obstetrical KitContents: (1) Glove L/F Pair, (1) Underpad 17x24, (2) Umbilical Clamps, (1) Umbilical Scissor, (2) Obstetrical Towelettes, (1) Obstetrical Pad, (1) Receiving Blanket, (2) Sponge 4x4 2/Pk, (1) Bulb Syringe, (3) Towels 3-Ply, (1) Infant Cap, (1) Apron, (2) Twist Ties, (1) Placenta Bag
Catalog Number
1737
Brand Name
Motion Medical Distributing
Version/Model Number
1737
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
9d717684-64c9-4f74-ae88-2a880db80de6
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
November 23, 2016
Package DI Number
25060498451073
Quantity per Package
10
Contains DI Package
15060498451076
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 |