FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Irrimax
DI: 10842351100025
·
Model: Max-101
·
IRRIMAX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Irrimax
- Primary DI
- 10842351100025
- Version / Model
- Max-101
- Catalog Number
- 0002
- Company Name
- IRRIMAX CORPORATION
- Labeler DUNS
- 142661078
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2017-07-03
- Public Version
- 5
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 99cec28b-9dd1-44fa-b312-b045385dabd7
- Distribution End Date
- 2021-06-01
Device Description
Irrimax Wound Irrigation System
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
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| KYZ | SYRINGE, IRRIGATING (NON DENTAL) | General Hospital | 880.6960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64871 | Non-antimicrobial wound irrigation solution, saline | A solution of sodium chloride (NaCl), without additional compounds (i.e., not a multiple solute solution), intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and may be supplied in a plastic container with a spray nozzle; it is intended to be used in the home or healthcare facility. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10842351100025 | GS1 | ||||
| Unit of Use | 00842351100028 | GS1 |
Customer Contacts
- Phone
- +1(844)232-9123
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 450 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius