FDA UDI
In Commercial Distribution
🇺🇸 United States
Aerochamber2go Anti-Static Valved Holding Chamber
DI: 00604351506121
·
Model: AeroChamber2go, cs/12
·
Monaghan Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Aerochamber2go Anti-Static Valved Holding Chamber
- Primary DI
- 00604351506121
- Version / Model
- AeroChamber2go, cs/12
- Company Name
- Monaghan Medical Corporation
- Labeler DUNS
- 056332380
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-30
- Public Version
- 1
- Public Version Date
- 2025-06-09
- Public Version Status
- New
- Public Device Record Key
- 83c52f17-899c-440c-b0ac-0c7975d05735
Device Description
AEROCHAMBER2GO CHAMBER, RETAIL
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
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| NVP | Holding Chambers, Direct Patient Interface | Anesthesiology | 868.5630 | 2 |
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 |
|---|---|---|---|---|---|---|
| Primary | 00604351506121 | GS1 | ||||
| Package | 50604351506126 | GS1 | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 518-561-7330
- [email protected]