FDA UDI In Commercial Distribution 🇺🇸 United States

Humidifier Kit

DI: 00848530084431 · Model: AMAS002RESKIT · SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Humidifier Kit
Primary DI
00848530084431
Version / Model
AMAS002RESKIT
Catalog Number
AMAS002RESKIT
Company Name
SUNSET HEALTHCARE SOLUTIONS, INC.
Labeler DUNS
141668116
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-07-31
Public Version
2
Public Version Date
2024-02-05
Public Version Status
Update
Public Device Record Key
c8aeb334-f09a-4696-b3dd-a3c491fdcf0b

Device Description

This kit contains: 1 RES050 Bubble Humidifier, 1 HUM008 Humidifier Connector, 1 RES1107 Adult Cannula w/ 7ft Tubing.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
60856 Oxygen administration kit

Identifiers

Type ID
Primary 00848530084431

Customer Contacts

Phone
877-578-6738