FDA UDI
In Commercial Distribution
🇺🇸 United States
Piston Irrigation Syringe, Ring Top Syringe, Non-Sterile, 60 cc
DI: 00616784426419
·
Model: 4264
·
Dynarex Corporation
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Piston Irrigation Syringe, Ring Top Syringe, Non-Sterile, 60 cc
- Primary DI
- 00616784426419
- Version / Model
- 4264
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-01
- Public Version
- 5
- Public Version Date
- 2024-10-17
- Public Version Status
- Update
- Public Device Record Key
- 88027387-b302-43d8-9905-ba1c0e2f86d6
Device Description
Contents Include: Thumb control ring top syringe, Catheter tip , Small tube adapter , Tip protector
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
| 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 | 00616784426433 | GS1 | Case | 30 | In Commercial Distribution | |
| Primary | 00616784426419 | GS1 |