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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDQ | Bottle, Collection, Vacuum | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62752 | Pleural drainage valve | A sterile, noninvasive device in the form of a small polymer housing intended to be connected to a pleural catheter to prevent backflow of gas into the pleural cavity during drainage of fluid and gas from the pleural cavity. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18034139291137 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 08034139291130 | GS1 |
Customer Contacts
- Phone
- +17868187337
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 60 Degrees Celsius