FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Monaghan
DI: 00604351886858
·
Model: Kit, Educational, MMC Z STAT™ aVHC
·
Monaghan Medical Corporation
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Monaghan
- Primary DI
- 00604351886858
- Version / Model
- Kit, Educational, MMC Z STAT™ aVHC
- Catalog Number
- 88685
- Company Name
- Monaghan Medical Corporation
- Labeler DUNS
- 056332380
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-12
- Public Version
- 4
- Public Version Date
- 2023-10-16
- Public Version Status
- Update
- Public Device Record Key
- 19918fa6-7e1f-44a4-b302-221cbfc3acf2
- Distribution End Date
- 2023-10-16
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38018 | Medicine chamber spacer, reusable | A device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50604351886853 | GS1 | Single | 1 | Not in Commercial Distribution | 2023-10-16 |
| Primary | 00604351886858 | GS1 |
Customer Contacts
- Phone
- 518-561-7330
- [email protected]