FDA UDI
Not in Commercial Distribution
🇺🇸 United States
n/a
DI: 00874750006243
·
Model: 4500
·
HANS RUDOLPH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- n/a
- Primary DI
- 00874750006243
- Version / Model
- 4500
- Catalog Number
- 112345
- Company Name
- HANS RUDOLPH, INC.
- Labeler DUNS
- 007131725
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 5
- Public Version Date
- 2023-06-30
- Public Version Status
- Update
- Public Device Record Key
- c88c1298-c836-49d9-b2b8-fc8ca7eaf38d
- Distribution End Date
- 2023-06-30
Device Description
4500A SERIES NON HTD PNT
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
- Yes
- 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 |
|---|---|---|---|---|
| JAX | Pneumotachometer | Anesthesiology | 868.2550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35245 | Pneumotachograph | A device designed to graphically record the instantaneous flow (velocity) of air at the mouth or, using an integrated signal, the volume of air per breath during inspiration or expiration. This recorder consists of a resistance attachment (e.g., wire screen or capillary tubes) placed in a tube in which the respiratory gases flow, the pressure drop being linearly related to airflow velocity. It is used for displaying the dynamics of respiration, and also can be used, in conjunction with an oesophageal balloon, to measure static lung compliance or airway resistance in conjunction with a whole-body plethysmograph. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00874750006243 | GS1 |