FDA UDI
In Commercial Distribution
🇺🇸 United States
Enteral
DI: 05060460848258
·
Model: ECISO-10
·
GBUK ENTERAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Enteral
- Primary DI
- 05060460848258
- Version / Model
- ECISO-10
- Catalog Number
- ECISO-10
- Company Name
- GBUK ENTERAL LIMITED
- Labeler DUNS
- 216643186
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-20
- Public Version
- 1
- Public Version Date
- 2022-10-28
- Public Version Status
- New
- Public Device Record Key
- 0ed53b80-1e2a-4093-86da-f7bdd6e282f8
Device Description
Enteral, Syringe Accessories, ENFit® Male Syringe Cap, Single Use 10/blister
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
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PNR | Enteral Syringes with enteral specific connectors | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65012 | ENFit-formatted protective cap | A small, noninvasive, closed-ended, ENFit-formatted (ISO 80369-3) attachment intended to be attached to an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060460848265 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 05060460848258 | GS1 | ||||
| Package | 05060460848272 | GS1 | Case | 24 | In Commercial Distribution |