FDA UDI
In Commercial Distribution
🇺🇸 United States
AIM
DI: 15099169457376
·
Model: 4500
·
VITALOGRAPH (IRELAND) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- AIM
- Primary DI
- 15099169457376
- Version / Model
- 4500
- Company Name
- VITALOGRAPH (IRELAND) LIMITED
- Labeler DUNS
- 219683489
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6d66d43a-5b84-47e6-a4eb-3c2904a60413
Device Description
45737
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| BWF | SPIROMETER, THERAPEUTIC (INCENTIVE) | Anesthesiology | 868.5690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42629 | Aerosol inhalation monitor | An electronic device intended to be used in the assessment and training of a patient's inhalation flow rates and "firing" coordination when using an aerosol metered dose inhaler (MDI) or a dry powder inhaler (DPI). It is typically known as an aerosol inhalation monitor (AIM), and includes a display/control panel, an electronic flowmeter, a placebo MDI aerosol canister, and a flowhead with mouthpiece. The patient demonstrates his/her inhalation technique while the healthcare provider observes their performance; a visual incentive training device to encourage and motivate the patient, especially children, may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05099169457379 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 15099169457376 | GS1 | ||||
| Package | 35099169457370 | GS1 | 25 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K893665 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity