FDA UDI In Commercial Distribution 🇺🇸 United States

High Flow O2 Kit

DI: 00848530089719 · Model: ACHE002O2KIT-HF · SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
High Flow O2 Kit
Primary DI
00848530089719
Version / Model
ACHE002O2KIT-HF
Catalog Number
ACHE002O2KIT-HF
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
01d2bb5d-c6aa-4163-bc1a-58f5eac31efa

Device Description

This kit contains: 2 RES003 Oxygen In Use Sign 2 RES1115HFV Adult Cannula with 15ft Supply Tube — High Flow, 2 RES1107HFV Adult Cannula with 7ft Supply Tube — High Flow, 1 RES3025 Oxygen Tube 25ft, 1 RES032 Cylinder Wrench, 1 RES002 Oxygen Connector with Swivel, 1 HUM008 Humidifier Connector 12in, 2 RES050 Bubble Humidifier, 1 RES037 Water Trap, 1 RES012 Tubing Connector.

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
No
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 00848530089719

Customer Contacts

Phone
877-578-6738