FDA UDI
In Commercial Distribution
🇺🇸 United States
AMSure® Cleansing Enema Bucket Set
DI: 10704411008385
·
Model: 1
·
AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AMSure® Cleansing Enema Bucket Set
- Primary DI
- 10704411008385
- Version / Model
- 1
- Catalog Number
- AS333
- Company Name
- AMSINO INTERNATIONAL, INC.
- Labeler DUNS
- 825673239
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-05
- Public Version
- 1
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 26e2f664-c89f-4a27-affb-5e22c6dec050
Device Description
AMSure® Cleansing Enema Bucket Set CONTENTS: 1 each 1500 mL Graduated Container 1 each 60" Administration Tubing with Prelubricated Tip 1 each Flow Control Clamp 1 each Packet Castile Soap 1 each Moistureproof Underpad
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCE | Enema Kit | Gastroenterology, Urology | 876.5210 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35050 | Gravity enema set | A collection of devices intended to be used to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine. It includes a fluid reservoir (e.g., enema bag) which acts as a gravity-flow chamber, and typically includes enema tube(s) and enema tip; it may be prefilled with a non-medicated enema solution and may be available preassembled. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40704411008386 | GS1 | case | 50 | In Commercial Distribution | |
| Primary | 10704411008385 | GS1 |