FDA UDI
In Commercial Distribution
🇺🇸 United States
3100
DI: 10190752155374
·
Model: 768968
·
VYAIRE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 3100
- Primary DI
- 10190752155374
- Version / Model
- 768968
- Catalog Number
- 768968
- Company Name
- VYAIRE MEDICAL, INC.
- Labeler DUNS
- 080456871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-12
- Public Version
- 1
- Public Version Date
- 2021-01-20
- Public Version Status
- New
- Public Device Record Key
- be1634af-d671-4143-99c7-750edc9c559b
Device Description
MOUNTING BRACKET, SMALL
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LSZ | VENTILATOR, HIGH FREQUENCY | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61952 | Frame/rail/pole device holder | A clamp-like device intended to be affixed to a bed frame, standard rail or standing pole [e.g., intravenous (IV) pole] to provide a means to fix/mount a medical device (e.g., suction/irrigation pump, display monitor), or other non-medical device, to the support. It typically has a gripping profile that is compatible with the device it is intended to fit. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190752155374 | GS1 |
Customer Contacts
- Phone
- +1(833)327-3284
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P890057 | 000 |