FDA UDI In Commercial Distribution 🇺🇸 United States

Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit

DI: 00709078004490 · Model: A9241 · WESTMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit
Primary DI
00709078004490
Version / Model
A9241
Company Name
WESTMED, INC.
Labeler DUNS
092673953
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-05-16
Public Version
3
Public Version Date
2019-12-24
Public Version Status
Update
Public Device Record Key
89940c60-7ea8-4f53-aeca-ddbb0a4f66f7

Device Description

Adult Heated Humidified Circuit, expandable up to 96"

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
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

GMDN Terms

Code Name
60966 Respiratory gas heating wire, adult

Identifiers

Type ID
Package 10709078004497
Primary 00709078004490

Premarket Submissions

Submission Number Supplement Number
K904538 000