FDA UDI
In Commercial Distribution
🇺🇸 United States
KBMED
DI: 00850016172129
·
Model: ES3
·
KB Medical (group), Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- KBMED
- Primary DI
- 00850016172129
- Version / Model
- ES3
- Company Name
- KB Medical (group), Inc.
- Labeler DUNS
- 105002071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-11-18
- Public Version
- 2
- Public Version Date
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- 697101ca-e64a-445e-bbc3-4304af746910
Device Description
Enteral Feeding Syringe 2.5ml blister packing
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| PNR | Enteral Syringes With Enteral Specific Connectors | Gastroenterology, Urology | 876.5980 | 2 |
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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00850016172020 | GS1 | ||||
| Primary | 00850016172129 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182649 | 000 |