FDA UDI In Commercial Distribution 🇺🇸 United States

Curaplex

DI: 00815277022019 · Model: 683922 · BOUND TREE MEDICAL, LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Curaplex
Primary DI
00815277022019
Version / Model
683922
Company Name
BOUND TREE MEDICAL, LLC
Labeler DUNS
070556204
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-12-14
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
7bc3e617-57ba-4a1c-a58d-282d853fe333

Device Description

BTM RAPID TREATMENT KIT

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
Yes
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

Product Codes

Code Name
OKH Body fluids barrier kit
CBP Valve, non-rebreathing
BTA PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

GMDN Terms

Code Name
44047 First aid kit, non-medicated, single-use

Identifiers

Type ID
Primary 00815277022019