FDA UDI
In Commercial Distribution
🇺🇸 United States
SealSafe
DI: 00187207000511
·
Model: 760028S
·
Andwin Scientific
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- SealSafe
- Primary DI
- 00187207000511
- Version / Model
- 760028S
- Company Name
- Andwin Scientific
- Labeler DUNS
- 028449445
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-14
- Public Version
- 1
- Public Version Date
- 2025-08-22
- Public Version Status
- New
- Public Device Record Key
- f32428d3-4a80-48df-a078-87b42992b8d2
Device Description
SEALSAFE® 28MM SELF-SEALING DOSING ADAPTER W/ SLIT SEPTUM 100/PK
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
- 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
- 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 |
|---|---|---|---|---|
| IQG | Adaptor, Holder, Syringe | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60539 | Vial/bottle adaptor, non-hermetic | A device intended to be fitted to a vial or bottle to enable the removal of its contents, (e.g., medication, nutritional solution for enteral feeding) into a syringe, for subsequent administration to a patient. It is typically a housing with a barbed connection or spike that attaches to or replaces the container lid, and a small bore connection (typically ENFit or a Luer); it does not allow for pressure equalization/airtight transfer of contents. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00187207000511 | GS1 | ||||
| Package | 01187207000053 | GS1 | BOX | 100 | In Commercial Distribution | |
| Package | 02187207000519 | GS1 | BAG | 20 | In Commercial Distribution | |
| Package | 03187207000518 | GS1 | BOX | 10 | In Commercial Distribution |