FDA UDI
In Commercial Distribution
🇺🇸 United States
AIV
DI: M745FM10835
·
Model: FM10835
·
AMERICAN IV PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AIV
- Primary DI
- M745FM10835
- Version / Model
- FM10835
- Catalog Number
- FM10835
- Company Name
- AMERICAN IV PRODUCTS, INC.
- Labeler DUNS
- 181184474
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9c4def9a-ea2d-44d6-baaf-c93c603e5a9c
Device Description
Fetal Transducer Philips Ultrasound
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HGL | Transducer, Ultrasonic, Obstetric | Obstetrics/Gynecology | 884.2960 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40761 | General-purpose ultrasound imaging system | A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M745FM10835 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040392 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 122.75 | Inch | |
| Height | 0.8 | Inch | |
| Outer Diameter | 2.75 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 140 Degrees Fahrenheit