FDA UDI Not in Commercial Distribution 🇺🇸 United States

Neo-Vent™,Humidified Infant T-Piece Resuscitation Kit

DI: 00709078002441 · Model: 0422 · WESTMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Neo-Vent™,Humidified Infant T-Piece Resuscitation Kit
Primary DI
00709078002441
Version / Model
0422
Company Name
WESTMED, INC.
Labeler DUNS
092673953
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-02-02
Public Version
4
Public Version Date
2023-09-29
Public Version Status
Update
Public Device Record Key
3803b6e8-f92d-493f-a669-44eb433dc839
Distribution End Date
2023-09-29

Device Description

Neo-Vent™,Humidified Infant T-Piece Resuscitation Kit

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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
BYE Attachment, Breathing, Positive End Expiratory Pressure

GMDN Terms

Code Name
36086 Pulmonary resuscitator, manual, single-use

Identifiers

Type ID
Package 10709078002448
Primary 00709078002441