FDA UDI
In Commercial Distribution
🇺🇸 United States
AMSure® Pediatric Urine Collector
DI: 10704411008057
·
Model: 1
·
AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- AMSure® Pediatric Urine Collector
- Primary DI
- 10704411008057
- Version / Model
- 1
- Catalog Number
- AS409
- Company Name
- AMSINO INTERNATIONAL, INC.
- Labeler DUNS
- 825673239
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-01
- Public Version
- 2
- Public Version Date
- 2023-01-10
- Public Version Status
- Update
- Public Device Record Key
- 25a07abf-f185-441d-af35-5449e3ad7de5
Device Description
AMSure® Pediatric Urine Collector
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EXI | Device, Paste-On For Incontinence, Sterile | Gastroenterology, Urology | 876.5250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63159 | Paediatric urine collection/analysis kit IVD | A collection of devices intended to be used to collect and analyse a paediatric urine specimen for multiple clinical chemistry analytes (e.g., ketones, glucose and pH). It consists of a specimen collection undergarment (nappy or diaper) worn by the patient, and quantitative test strips for various clinical chemistry analytes. Results are analysed visually or with dedicated interpretive software (not included). It can be used at home by a caregiver and at the point-of-care by a healthcare professional. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40704411008058 | GS1 | case | 10 | In Commercial Distribution | |
| Package | 30704411008051 | GS1 | box | 50 | In Commercial Distribution | |
| Primary | 10704411008057 | GS1 |