FDA UDI
In Commercial Distribution
🇺🇸 United States
HydroMax HMEF
DI: 00817081026719
·
Model: HydroMax HMEF - 158250
·
A-M SYSTEMS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HydroMax HMEF
- Primary DI
- 00817081026719
- Version / Model
- HydroMax HMEF - 158250
- Catalog Number
- 158250
- Company Name
- A-M SYSTEMS, LLC
- Labeler DUNS
- 020275145
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-08
- Public Version
- 2
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- 33a38c38-f268-4673-bbaf-02db74126faf
Device Description
HydroMax, Disposable, Heat and Moisture Exchange
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | Anesthesiology | 868.5260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46816 | Heat/moisture exchanger/microbial medical gas filter | A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00817081026726 | GS1 | 200 | In Commercial Distribution | ||
| Primary | 00817081026719 | GS1 |
Customer Contacts
- Phone
- 3606838300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130664 | 000 |