FDA UDI
In Commercial Distribution
🇺🇸 United States
CareTip
DI: 05060590883709
·
Model: ABOSPFCO-1-500NS
·
GBUK ENTERAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
500
Basic Information
- Brand Name
- CareTip
- Primary DI
- 05060590883709
- Version / Model
- ABOSPFCO-1-500NS
- Catalog Number
- ABOSPFCO-1-500NS
- Company Name
- GBUK ENTERAL LIMITED
- Labeler DUNS
- 216643186
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2022-11-01
- Public Version
- 1
- Public Version Date
- 2022-11-09
- Public Version Status
- New
- Public Device Record Key
- 04460890-e2f1-40fb-bded-9ad45cbde4f2
Device Description
CareTip, Oral Syringe, Amber Barrel, Single Use 1ml
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYX | DISPENSER, LIQUID MEDICATION | General Hospital | 880.6430 | 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 | 05060590883860 | GS1 | Case | 8 | In Commercial Distribution | |
| Primary | 05060590883709 | GS1 | ||||
| Unit of Use | 45060590883707 | GS1 |