FDA UDI
In Commercial Distribution
🇺🇸 United States
Venti.Plus
DI: 04710810117374
·
Model: H025
·
GALEMED CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Venti.Plus
- Primary DI
- 04710810117374
- Version / Model
- H025
- Catalog Number
- Hyperinflation System 0.25L
- Company Name
- GALEMED CORPORATION
- Labeler DUNS
- 656854379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- 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
- 6c06dbd8-adb1-4bdf-a9dd-5bda34c00277
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
- 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 |
|---|---|---|---|---|
| NHK | Resuscitator,Manual,Non Self-Inflating | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35176 | Anaesthesia face mask, reusable | A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 44710810117372 | GS1 | Carton | 20 | In Commercial Distribution | |
| Primary | 04710810117374 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092687 | 000 |