FDA UDI In Commercial Distribution 🇺🇸 United States

Portex

DI: 15019315035562 · Model: Z115-16 · SMITHS MEDICAL ASD, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Portex
Primary DI
15019315035562
Version / Model
Z115-16
Company Name
SMITHS MEDICAL ASD, INC.
Labeler DUNS
137835299
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-19
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
fc946bd3-f297-4d94-9763-41ac3dc06394

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
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
Yes
Sterilization Prior Use
No

Product Codes

Code Name
CAF NEBULIZER (DIRECT PATIENT INTERFACE)
BSY CATHETERS, SUCTION, TRACHEOBRONCHIAL

GMDN Terms

Code Name
34041 Tracheobronchial suction/insufflation catheter, single-lumen

Identifiers

Type ID
Package 35019315035566
Primary 15019315035562