FDA UDI Not in Commercial Distribution 🇺🇸 United States

Curaplex

DI: 00818834026161 · Model: 301-0318LTMSA-PED · TRI-ANIM HEALTH SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Curaplex
Primary DI
00818834026161
Version / Model
301-0318LTMSA-PED
Catalog Number
301-0318LTMSA-PED
Company Name
TRI-ANIM HEALTH SERVICES, INC.
Labeler DUNS
010712461
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-07-01
Public Version
2
Public Version Date
2021-01-14
Public Version Status
Update
Public Device Record Key
678973fa-01e0-4356-93ad-87291b824f5d
Distribution End Date
2020-12-18

Device Description

Pediatric Procedural Oxygen Mask with High Concentration & CO2 Monitoring (Microstream™ Compatible)

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
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
62179 Capnography oxygen mask

Identifiers

Type ID
Package 00818834026178
Primary 00818834026161