FDA UDI In Commercial Distribution 🇺🇸 United States

Konmed

DI: 06970935830345 · Model: CPR Pocket Mask Model:KM-102 · Shenzhen Konmed Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Konmed
Primary DI
06970935830345
Version / Model
CPR Pocket Mask Model:KM-102
Company Name
Shenzhen Konmed Technology Co., Ltd.
Labeler DUNS
544436531
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-01-24
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
9350c367-c553-4a80-be5d-4ecc8dd4adb2

Device Description

This CPR mask is designed for mouth to mask ventilation of a non-breathing adult, child, or infant. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
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
BYP Mouthpiece, Breathing

GMDN Terms

Code Name
61326 Cardiopulmonary resuscitation mask, single-use

Identifiers

Type ID
Primary 06970935830345