FDA UDI In Commercial Distribution 🇺🇸 United States

Ever Ready First Aid

DI: 06946430401809 · Model: CP641000+CP641007+2A+PG · XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Ever Ready First Aid
Primary DI
06946430401809
Version / Model
CP641000+CP641007+2A+PG
Company Name
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Labeler DUNS
543482946
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-08-10
Public Version
2
Public Version Date
2019-08-21
Public Version Status
Update
Public Device Record Key
81b641ac-5d77-488e-9f95-5f0754728bc0

Device Description

Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Oxygen Port, two pieces alcohol pads and one pair PVC glove. CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. Infant CPR Mask without Oxygen Port is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It also functions as a barrier that will direct expired air from the patient away from the user. It is intended for over the counter use for infants with body weight up to 10kg (22 lbs).

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
35693 Cardiopulmonary resuscitation kit, single-use

Identifiers

Type ID
Package 16946430401806
Primary 06946430401809