FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 24710810080382
·
Model: 1325
·
GALEMED CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
4
Basic Information
- Brand Name
- N/A
- Primary DI
- 24710810080382
- Version / Model
- 1325
- Catalog Number
- CPR Super Pocket Mask
- Company Name
- GALEMED CORPORATION
- Labeler DUNS
- 656854379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 5b53be7f-d46b-426a-a12f-7dc13ac672bd
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CBP | Valve, Non-Rebreathing | Anesthesiology | 868.5870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35425 | Non-rebreathing valve, reusable | A non-sterile device that is a one-way valve used to direct the flow of breathing gases and prevent the patient rebreathing the exhaled gases. It is typically used in a breathing system or between an oxygen mask and its reservoir bag. The device may be of various designs and will typically include unidirectional valves made of, e.g., silicone, rubber, metal, mica, sheets or discs that open and close for each inspiration/expiration. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 44710810080386 | GS1 | Carton | 12 | In Commercial Distribution | |
| Primary | 24710810080382 | GS1 | ||||
| Unit of Use | 94710810080381 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K953230 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius