FDA UDI
In Commercial Distribution
🇺🇸 United States
INTL DMDM,STANDARD-AUSTRALIA
DI: 00816711023876
·
Model: 91525184
·
PARKER-HANNIFIN CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- INTL DMDM,STANDARD-AUSTRALIA
- Primary DI
- 00816711023876
- Version / Model
- 91525184
- Catalog Number
- 91525184
- Company Name
- PARKER-HANNIFIN CORPORATION
- Labeler DUNS
- 004175550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-05
- Public Version
- 2
- Public Version Date
- 2025-02-24
- Public Version Status
- Update
- Public Device Record Key
- d09f850e-3536-4e2a-8f76-66227cec8222
Device Description
40151615 Digital MDM, 30% Australia / N.Z.
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 |
|---|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | Anesthesiology | 868.5160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44159 | Oxygen/air/nitrous oxide breathing gas mixer | An independent mechanical device designed for accurate mixing of oxygen (O2) and air or O2 and nitrous oxide (N2O) in pre-set concentrations appropriated for breathing. The mixer receives all three gases from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. It usually delivers the gases with adjustable N2O or air concentrations and ensures a minimum O2 level to the patient through a face mask, mouthpiece, or endotracheal (ET) tube. It is used to improve O2 uptake and/or relieve pain throughout a hospital, during dental procedures, or in obstetrics during labour. It may also be attached to ventilators or anaesthesia machines. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816711023876 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K884879 | 000 |