FDA UDI
In Commercial Distribution
🇺🇸 United States
Aquarius
DI: 07290000846293
·
Model: 16605030680AQ
·
DEGANIA SILICONE LTD
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Aquarius
- Primary DI
- 07290000846293
- Version / Model
- 16605030680AQ
- Company Name
- DEGANIA SILICONE LTD
- Labeler DUNS
- 600007082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-31
- Public Version
- 2
- Public Version Date
- 2023-10-10
- Public Version Status
- Update
- Public Device Record Key
- 1274198d-86d3-4e3d-abf6-1ae334086641
Device Description
Pediatric NG with Stylet 6FR 50cm Ster.NG-4-06S
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 |
|---|---|---|---|---|
| FPD | Tube, Feeding | Gastroenterology, Urology | 876.5980 | 2 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38561 | Nasogastric/orogastric tube | A sterile, hollow cylinder that can be introduced into the gastrointestinal (GI) tract both nasally and orally for feeding and/or aspiration. It is made of plastic or rubber and is available in a variety of designs and lengths. Some types are a simple rubber tube with a glass window; other types can be radiopaque to assist accurate placement, have multiple flow-through eyes, and dual connectors (e.g., one for suction and the other for irrigation/feeding). Other uses can be to decompress the stomach, withdraw specimens for diagnostic analysis, administer medications, and for irrigation of the stomach to treat upper gastrointestinal (UGI) bleeding. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 27290000846297 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 07290000846293 | GS1 | ||||
| Package | 47290000846291 | GS1 | 10 | In Commercial Distribution |