Model: 120004997
Catalog: 570302-RN
DI: 00812120005083
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2bccea02-7d04-4815-837d-029fc2147870
Distribution Status:
In Commercial Distribution
DUNS Number:
079375431
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00812120005083
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61228
Name: External cuff/pad connection tubing
Definition:
A length of flexible tube intended to be used to deliver air and/or fluid from a pump to a noninvasive, patient-contact pad, pack or cuff. It may be intended for use with a specific type of assembly (e.g., circulating-air/fluid thermal therapy system, electronic sphygmomanometer, venous compression system). It is typically made of synthetic material and may be intended to be permanently attached to the system control unit. This is a reusable device.
FDA Product Codes
IRP
Massager, powered inflatable tube
ILO
Pack, hot or cold, water circulating
Device Sizes
Device Size - Size - @attributes - Unit:
Feet
Device Size - Size - @attributes - Value:
6
Device Size - Size Type:
Length