FDA UDI In Commercial Distribution 🇺🇸 United States

Heimlich valve

DI: 08034139291130 · Model: 10530 · REDAX SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Heimlich valve
Primary DI
08034139291130
Version / Model
10530
Catalog Number
10530
Company Name
REDAX SPA
Labeler DUNS
338664915
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-03-27
Public Version
1
Public Version Date
2020-04-06
Public Version Status
New
Public Device Record Key
dcd45105-c159-4137-8f56-dda2e5bd6ff1

Device Description

The Heimlich non-return valve is a one-way drainage device which prevents the air reflux towards the patient's chest.

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
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KDQ Bottle, Collection, Vacuum

GMDN Terms

Code Name
62752 Pleural drainage valve

Identifiers

Type ID
Package 18034139291137
Primary 08034139291130

Customer Contacts

Phone
+17868187337

Storage Conditions

Type
Storage Environment Humidity
Temperature Range
10 – 90 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
0 – 60 Degrees Celsius