FDA UDI In Commercial Distribution 🇺🇸 United States

Curaplex

DI: 00817617022956 · Model: 355-3222-EEA · BOUND TREE MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Curaplex
Primary DI
00817617022956
Version / Model
355-3222-EEA
Catalog Number
355-3222-EEA
Company Name
BOUND TREE MEDICAL, LLC
Labeler DUNS
070556204
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-09-04
Public Version
3
Public Version Date
2018-05-23
Public Version Status
Update
Public Device Record Key
2b0e6de7-a478-4919-baa3-14bdacf2c96a

Device Description

Oxygen Mask, Med O2 Elongated Ped,

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
BYG MASK, OXYGEN

GMDN Terms

Code Name
35171 Rebreathing oxygen face mask

Identifiers

Type ID
Package 00817617023434
Primary 00817617022956