FDA UDI In Commercial Distribution 🇺🇸 United States

CATH-SECURE Advanced

DI: 00048329000158 · Model: 54456ADV · M.C. JOHNSON CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
CATH-SECURE Advanced
Primary DI
00048329000158
Version / Model
54456ADV
Company Name
M.C. JOHNSON CO., INC.
Labeler DUNS
112853395
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-06-09
Public Version
1
Public Version Date
2021-06-17
Public Version Status
New
Public Device Record Key
06c24722-7b7f-43d2-aab9-f24ca38349b5

Device Description

ADVANCED MEDICAL SECUREMENT DEVICE FOR FOLEY CATHETER, Skin Preparation Barrier Wipe included

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EYJ Holder, Ureteral Catheter

GMDN Terms

Code Name
57982 Urinary catheter holder

Identifiers

Type ID
Package 10048329000155
Primary 00048329000158
Package 20048329000152

Customer Contacts

Phone
2394331538