FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Flexichamber
DI: 00313551000000
·
Model: Anti-Static Valved Collapsible Holding Chamber
·
AVADEL PHARMACEUTICALS (USA), INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Flexichamber
- Primary DI
- 00313551000000
- Version / Model
- Anti-Static Valved Collapsible Holding Chamber
- Catalog Number
- 902-100
- Company Name
- AVADEL PHARMACEUTICALS (USA), INC.
- Labeler DUNS
- 169886244
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 3
- Public Version Date
- 2018-11-08
- Public Version Status
- Update
- Public Device Record Key
- 838dfae8-91fe-4bf2-86cd-9a97a4337e1f
- Distribution End Date
- 2018-11-07
Device Description
DEMO UNIT
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
- 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 |
|---|---|---|---|---|---|---|
| Package | 00313551000017 | GS1 | Carton Box | 44 | Not in Commercial Distribution | 2018-11-07 |
| Primary | 00313551000000 | GS1 |