FDA UDI
In Commercial Distribution
🇺🇸 United States
AdviewII™
DI: 00634782101619
·
Model: 9005SMC
·
AMERICAN DIAGNOSTIC CORP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AdviewII™
- Primary DI
- 00634782101619
- Version / Model
- 9005SMC
- Catalog Number
- 9005SMC
- Company Name
- AMERICAN DIAGNOSTIC CORP
- Labeler DUNS
- 108999095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-30
- Public Version
- 1
- Public Version Date
- 2026-04-07
- Public Version Status
- New
- Public Device Record Key
- 0d598176-5737-456e-b59b-15f6d34d7804
Device Description
Adview2 SpO2 Finger Sensor, Adult, 9' cable, M-tech comp
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16173 | Automatic-inflation electronic sphygmomanometer, non-portable | An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00634782101619 | GS1 |
Customer Contacts
- Phone
- 1-800-232-2670
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082846 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Adult, 40kg or greater |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 113 Degrees Fahrenheit