FDA UDI
In Commercial Distribution
🇺🇸 United States
Saljet
DI: 50188151000003
·
Model: Saljet 20
·
WINCHESTER LABORATORIES LLLP
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- Saljet
- Primary DI
- 50188151000003
- Version / Model
- Saljet 20
- Company Name
- WINCHESTER LABORATORIES LLLP
- Labeler DUNS
- 038838914
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2024-07-05
- Public Version
- 1
- Public Version Date
- 2024-07-15
- Public Version Status
- New
- Public Device Record Key
- 42ea0947-9fd0-4716-ae16-b780b7cfc639
Device Description
Saljet is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into a shelf carton. Twenty vials per carton.
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
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64871 | Non-antimicrobial wound irrigation solution, saline | A solution of sodium chloride (NaCl), without additional compounds (i.e., not a multiple solute solution), intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and may be supplied in a plastic container with a spray nozzle; it is intended to be used in the home or healthcare facility. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60188151000000 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 50188151000003 | GS1 | ||||
| Unit of Use | 00188151000015 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K993969 | 000 |