FDA UDI
In Commercial Distribution
🇺🇸 United States
5530 3L SYRINGE
DI: 00817136026909
·
Model: 5530
·
HANS RUDOLPH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 5530 3L SYRINGE
- Primary DI
- 00817136026909
- Version / Model
- 5530
- Catalog Number
- 113924
- Company Name
- HANS RUDOLPH, INC.
- Labeler DUNS
- 007131725
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-08
- Public Version
- 1
- Public Version Date
- 2022-08-16
- Public Version Status
- New
- Public Device Record Key
- 0391e443-504a-40ab-815b-eef9fdc0d0f4
Device Description
5530 3L SYR NDD OUTLET
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
- 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 |
|---|---|---|---|---|
| BXW | Calibrator, Volume, Gas | Anesthesiology | 868.1870 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17250 | Spirometer/pulmonary function analyser syringe | A dedicated piston-in-barrel used for injecting small volumes of accurately measured amounts of gas into a spirometer, pulmonary function analyser, or other diagnostic pulmonary measuring/testing device for calibration or reference. It is typically a glass or plastic cylinder (barrel) and steel plunger (piston) with a finely graduated scale along the length of the cylinder. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817136026909 | GS1 |