FDA UDI
In Commercial Distribution
🇺🇸 United States
Enteral
DI: 05060460845677
·
Model: CT60
·
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
- 05060460845677
- Version / Model
- CT60
- Catalog Number
- CT60
- 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
- 1b0f3966-c545-4726-9e3e-e4c239de15b3
Device Description
Enteral, Syringe, CareTip Catheter Tip, Single Use 60ml
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
- Yes
- 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 |
|---|---|---|---|---|
| KYZ | SYRINGE, IRRIGATING (NON DENTAL) | General Hospital | 880.6960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59040 | ENFit oral/enteral syringe, single-use | A manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060460845684 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 05060460845677 | GS1 | ||||
| Package | 05060460845691 | GS1 | Case | 8 | In Commercial Distribution |