FDA UDI In Commercial Distribution 🇺🇸 United States

Invacare Perfect O2 Kit

DI: 00848530081324 · Model: OF9004SP-1 · SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Invacare Perfect O2 Kit
Primary DI
00848530081324
Version / Model
OF9004SP-1
Catalog Number
OF9004SP-1
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
1
Public Version Date
2018-08-31
Public Version Status
New
Public Device Record Key
e6acf414-1997-42c0-a5a3-26a1255b7cc4

Device Description

This kit contains: 1 OF9004 Foam Cabinet Filters, 1 BFH6S HEPA FIlter, 1 BF516 Final Bacteria Filter.

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
31245 Anaesthesia conduction filter

Identifiers

Type ID
Primary 00848530081324

Customer Contacts

Phone
877-578-6738