FDA UDI
In Commercial Distribution
🇺🇸 United States
Aquarius
DI: 07290000846569
·
Model: 1032560080AQ
·
DEGANIA SILICONE LTD
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Aquarius
- Primary DI
- 07290000846569
- Version / Model
- 1032560080AQ
- Company Name
- DEGANIA SILICONE LTD
- Labeler DUNS
- 600007082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 2
- Public Version Date
- 2024-02-23
- Public Version Status
- Update
- Public Device Record Key
- b76fab1f-332e-4800-ae20-f07a30730ab7
Device Description
Feeding set 60cm E.Set Y ENFit feed & straight conn.
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62256 | Enteral tube extension | A thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration. It is typically a single-lumen, rubber or plastic tube of various diameters/lengths. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 27290000846563 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 07290000846569 | GS1 | ||||
| Package | 47290000846567 | GS1 | 10 | In Commercial Distribution |