SealSafe

Basic Information

• Brand Name: SealSafe
• Primary DI: 00187207000481
• Version / Model: 760020P
• 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: 07077cea-8962-4978-8bdc-82b1557e01c9

Device Description

SEALSAFE® 20MM SELF-SEALING DOSING ADAPTER W/ PIERCED SEPTUM

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	00187207000481	GS1
Package	01187207000046	GS1	BOX	100	In Commercial Distribution
Package	02187207000489	GS1	BAG	20	In Commercial Distribution
Package	03187207000488	GS1	BOX	10	In Commercial Distribution