FDA UDI In Commercial Distribution 🇺🇸 United States

Neo-Pod™ "T"

DI: 00709078005022 · Model: 9403U · WESTMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Neo-Pod™ "T"
Primary DI
00709078005022
Version / Model
9403U
Company Name
WESTMED, INC.
Labeler DUNS
092673953
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-10-20
Public Version
4
Public Version Date
2018-07-12
Public Version Status
Update
Public Device Record Key
0295aa0f-40e7-412c-b804-18e6857809cb

Device Description

Universal neonatal transport circuit w/ Lavabed, exhalation valve

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

GMDN Terms

Code Name
12050 Heated respiratory humidifier

Identifiers

Type ID
Package 10709078005029
Primary 00709078005022

Premarket Submissions

Submission Number Supplement Number
K870173 000