FDA UDI
In Commercial Distribution
🇺🇸 United States
IS60ENOC
DI: 10816336020004
·
Model: IS60ENOC
·
NEOCHILD, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- IS60ENOC
- Primary DI
- 10816336020004
- Version / Model
- IS60ENOC
- Company Name
- NEOCHILD, LLC
- Labeler DUNS
- 022760922
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-12
- Public Version
- 2
- Public Version Date
- 2024-12-23
- Public Version Status
- Update
- Public Device Record Key
- 1e60b22f-be7a-463d-8c2a-b703f2294918
Device Description
Enteral Only Tubing 60" with Step Connector Cap
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62256 | Enteral tube extension, single-use | A thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube, gastrostomy 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 | 02081633602005 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 10816336020004 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082710 | 000 |