Model: PL45CPVH1
Catalog: PL45CPVH1
DI: 10198956446786
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
KIT, C SECTION
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c4739e2f-815a-4010-8729-d6da41f51509
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:
50198956446784
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
2
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10198956446786
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10198956446786
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 44071
Name: Amniocentesis kit, non-medicated
Definition:
A collection of sterile devices designed to aspirate and contain a sample of amniotic fluid from the amniotic sac, via a transabdominal approach, for analysis. Components typically include a needle with stylet and syringe, specimen containers/medium, drapes, and dressings. The device is typically used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities (e.g., Down syndrome, spina bifida), or anytime after 24-weeks gestation to assess foetal maturity. This is a single-use device.
FDA Product Codes
OHM
Cesarean section tray
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