FDA UDI
In Commercial Distribution
🇺🇸 United States
VIVE
DI: 00810041981752
·
Model: LVA2045
·
VIVE HEALTH LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VIVE
- Primary DI
- 00810041981752
- Version / Model
- LVA2045
- Company Name
- VIVE HEALTH LLC
- Labeler DUNS
- 047025993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-06
- Public Version
- 1
- Public Version Date
- 2020-04-14
- Public Version Status
- New
- Public Device Record Key
- db12ead1-f2c2-459e-a30d-21f68b159d09
Device Description
Face Masks 100 Pack
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KHA | Mask, Scavenging | Anesthesiology | 868.5590 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33523 | Scavenging anaesthesia face mask | A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic/analgesic gases to the upper airway, while capturing any gas that leaks past the device's rim. It is typically designed with a soft rim that seals against the patient's face, and an outer casing, or some other mechanism, that directs the exhaled respiratory and waste gases into a gas scavenging device. It typically includes a 22 mm connector and is used in situations where it is difficult to achieve an airtight seal to a patient's face, or when an analgesic gas is administered (e.g., during birthing). It is typically stabilized with a headstrap. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810041981759 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 00810041981752 | GS1 |