Duns Number:025460908
Device Description: NEO-NATAL IV START KIT
Catalog Number
P552037A
Brand Name
Medline Industries, Inc.
Version/Model Number
P552037A
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111577,K111577
Product Code
LHI
Product Code Name
Set, i.V. Fluid transfer
Public Device Record Key
5931459f-12f5-4c4e-8c90-82c772a8d759
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
March 20, 2022
Package DI Number
40889942499282
Quantity per Package
100
Contains DI Package
10889942499281
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |