FDA.reportPublic FDA data

SealSafe

Primary DI
00187207000511
Brand
SealSafe
Company
Andwin Scientific
Model
760028S
Device description
SEALSAFE® 28MM SELF-SEALING DOSING ADAPTER W/ SLIT SEPTUM 100/PK
Published
2025-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IQGAdaptor, Holder, Syringe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQGAdaptor, Holder, SyringePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01187207000053PackageGS1100In Commercial Distribution
02187207000519PackageGS120In Commercial Distribution
03187207000518PackageGS110In Commercial Distribution
00187207000511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01187207000053011872070000531187207000053
02187207000519021872070005192187207000519
03187207000518031872070005183187207000518
00187207000511001872070005111872070005110187207000511

GMDN Terms#

Term, Definition table
TermDefinition
Vial/bottle adaptor, non-hermeticA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
028449445
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00187207000467SealSafe760024P2025-08-14
00187207000474SealSafe760024S2025-08-14
00187207000481SealSafe760020P2025-08-14
00187207000498SealSafe760020S2025-08-14
00187207000504SealSafe760028P2025-08-14
00187207000351Andwin 8901812019-05-22
00187207000382Andwin Scientific8901832019-05-22
00187207000412Andwin Scientific8901852019-05-22
20187207000362Andwin Scientific8901822019-05-22
20187207000393Andwin Scientific8901842019-05-22
20187207000423Andwin Scientific8901862019-05-22
30187207000437Andwin Scientific8901872019-05-22
00187207000085Andwin Scientific2310572017-08-02
00187207000092Andwin Scientific2301102017-08-02
00187207000108Andwin Scientific2301002017-08-02
00187207000122Andwin Scientific2301802017-08-02
00187207000139Andwin Scientific2300802017-08-02
00187207000146Andwin Scientific2300752017-08-02
00187207000153Andwin Scientific2301602017-08-02
00187207000160Andwin Scientific2301522017-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974405095074CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405095173CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405095180CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097290CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097306CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097313CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097320CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097559CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
00854073007103VIVI CAP SMARTTempramedIQG2025-12-09
00854073007127VIVI MEDTempramedIQG2025-12-09
00187207000467SealSafeAndwin ScientificIQG2025-08-14
00187207000474SealSafeAndwin ScientificIQG2025-08-14
00187207000481SealSafeAndwin ScientificIQG2025-08-14
00187207000498SealSafeAndwin ScientificIQG2025-08-14
00187207000504SealSafeAndwin ScientificIQG2025-08-14
00817771028849Celling Cardio Application KitCelling BiosciencesIQG2025-04-11
00817771029600Celling Application KitCelling BiosciencesIQG2025-04-11
00860425001620Certa Dose PALS Syringe Holder CD Acquisitions, LLCIQG2025-03-03
00614950030163ACEACE SURGICAL SUPPLY CO., INC.IQG2023-12-05
00614950031191ACEACE SURGICAL SUPPLY CO., INC.IQG2023-12-05
00614950031320ACEACE SURGICAL SUPPLY CO., INC.IQG2023-12-05
00850003042305Extremity CareExtremity CareIQG2023-03-30
00854073007097VIVI EPITempramedIQG2022-09-01
00612479259966McKessonMCKESSON MEDICAL-SURGICAL INC.IQG2021-12-02
00612479259973McKessonMCKESSON MEDICAL-SURGICAL INC.IQG2021-12-02
08054083008172AbbVie Lightweight Vest XSABBVIE INC.IQG2021-10-19
08054083008189AbbVie Lightweight Vest SABBVIE INC.IQG2021-10-19
08054083008196AbbVie Lightweight Vest MABBVIE INC.IQG2021-10-19
08054083008202AbbVie Lightweight Vest LABBVIE INC.IQG2021-10-19
08054083008219AbbVie Lightweight Vest XLABBVIE INC.IQG2021-10-19