Model: 79442B
DI: 10809160520291
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Distribution End: 2026-04-28
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2914ec8c-d929-4891-bf73-1c71f897264b
Distribution Status:
Not in Commercial Distribution
DUNS Number:
092364462
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
Yes
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
20809160520298
Item #1 - Pkg Status:
Not in Commercial Distribution
Item #1 - Pkg Quantity:
20
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10809160520291
Item #1 - Pkg Discontinue Date:
2026-04-28
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10809160520291
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 32142
Name: Haemodialysis start/stop set
Definition:
A collection of instruments and associated items used for the start and/or stop procedures (also known as ON and OFF procedures) for a patient undergoing haemodialysis. It typically includes items such as syringes, needles, dressings, swabs, forceps, and protective wear for the healthcare provider such as gloves, face mask, and a gown. This device is used for the connection session and/or the disconnection session where the patient is connected/disconnected to the haemodialysis system. It does not include pharmaceuticals and typically does not include catheters. This is a single-use device.
FDA Product Codes
PEV
Dialysis administration kit
Environmental Conditions
Item #1 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
STORE AT ROOM TEMPERATURE