Model: SMACGDPA13
Catalog: SMACGDPA13
DI: 10198956462809
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
ARN DELIVERY PK
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
29b583de-9c73-4768-82ad-f41290ebc2a8
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:
50198956462807
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
3
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10198956462809
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10198956462809
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