FDA UDI
In Commercial Distribution
🇺🇸 United States
Medical Shipment
DI: 00850056286046
·
Model: 12001
·
Medical Shipment, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medical Shipment
- Primary DI
- 00850056286046
- Version / Model
- 12001
- Company Name
- Medical Shipment, LLC
- Labeler DUNS
- 962616673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-28
- Public Version
- 1
- Public Version Date
- 2023-09-05
- Public Version Status
- New
- Public Device Record Key
- b8bfd53c-afb8-428b-9f77-62fd51a9e9d2
Device Description
Irrigation Tray w/ 60mL Piston Syringe, 1/each
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 11371 | Ear canal irrigation kit, single-use | A collection of items intended to be used to flush cerumen (ear wax) out of the ear canal during an ear/nose/throat (ENT) procedure. It consists of a manual syringe and other accessory items. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850056286046 | GS1 | ||||
| Package | 00850056286053 | GS1 | Case | 20 | In Commercial Distribution |