Model: SMA7EDPR14
Catalog: SMA7EDPR14
DI: 10198956465381
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
DELIVERY PACK
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0c3a9cac-7aaf-4952-8fd6-136ca0b8f014
Distribution Status:
In Commercial Distribution
DUNS Number:
961027315
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
CASE
Item #1 - Device ID:
50198956465389
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
4
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10198956465381
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10198956465381
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 34988
Name: Birthing/delivery kit
Definition:
A collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this procedure. This is a single-use device.
FDA Product Codes
MLS
Labor and Delivery Kit
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
15
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
30
Storage Handling - Storage Handling Type:
Storage Environment Temperature