FDA UDI
Not in Commercial Distribution
🇺🇸 United States
7450 RV2 MASK
DI: 00817136027708
·
Model: 7450
·
HANS RUDOLPH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 7450 RV2 MASK
- Primary DI
- 00817136027708
- Version / Model
- 7450
- Catalog Number
- 113885
- Company Name
- HANS RUDOLPH, INC.
- Labeler DUNS
- 007131725
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-15
- Public Version
- 2
- Public Version Date
- 2024-10-28
- Public Version Status
- Update
- Public Device Record Key
- ab9b5843-0e06-4866-a10a-ba59ca07b1ac
- Distribution End Date
- 2024-10-25
Device Description
7450V2 PT W/HG & 2730 NRBV NO SMP
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
- Yes
- 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 |
|---|---|---|---|---|
| KGB | Mask, Oxygen, Non-Rebreathing | Anesthesiology | 868.5570 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37068 | Pulmonary function valve | A non-sterile, dedicated valve intended to be used with a parent device for the measurement/analysis of a patient's pulmonary function. It is typically used to control inspired/expired gas directional flow and assist in the inhalation and distribution of test gases. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817136027708 | GS1 |