FDA UDI In Commercial Distribution 🇺🇸 United States

2-lumen Abdominal Pressure Catheter 9 Fr. Latex (200mm)

DI: 10627825007372 · Model: 9021P4392 · Laborie Medical Technologies Canada ULC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
2-lumen Abdominal Pressure Catheter 9 Fr. Latex (200mm)
Primary DI
10627825007372
Version / Model
9021P4392
Company Name
Laborie Medical Technologies Canada ULC
Labeler DUNS
203383526
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-21
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
3ae69c6d-55a4-44b4-b9e1-d558ebf64fcf

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
Yes
Sterilization Methods
Ethylene Oxide

Product Codes

Code Name
FEN DEVICE, CYSTOMETRIC, HYDRAULIC

GMDN Terms

Code Name
62244 Urodynamic manometric catheter, non-electronic

Identifiers

Type ID
Package 20627825007379
Primary 10627825007372
Package 30627825007376