FDA.reportPublic FDA data

Wealy

Primary DI
06971603585192
Brand
Wealy
Company
Shantou Wealy Medical Instrument Co., Ltd.
Model
20ml
Device description
The ENFit® Reusable Enteral Syringe is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.
Published
2022-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PNREnteral Syringes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNREnteral Syringes With Enteral Specific ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203613000ENFit Reusable Enteral SyringeShantou Wealy Medical Instrument Co.,Ltd2021-08-27PNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971603585208PackageGS180In Commercial Distribution
06971603585215PackageGS110In Commercial Distribution
06971603585192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971603585208069716035852086971603585208
06971603585215069716035852156971603585215
06971603585192069716035851926971603585192

GMDN Terms#

Term, Definition table
TermDefinition
ENFit oral/enteral syringe, reusableA manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a reusable device.

Regulatory Flags#

DUNS number
545570186
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971603585222Wealy60ml2022-10-13
06971603585239Wealy60ml2022-10-13
06971603580500Wealy"3ml 25Gx1"""2021-04-25
06971603580579Wealy"3ml 25Gx5/8"""2021-04-25
06971603580531Wealy3ml 25Gx1"2021-04-25
06971603580586Wealy3ml 25Gx5/8"2021-04-25
06971603580487Wealy"3ml 23Gx1"""2021-03-20
06971603580517Wealy3ml 23Gx1"2021-03-20
06971603580326Wealy"10ml 22Gx1 1/2"""2020-12-29
06971603580371Wealy10ml 22Gx1 1/2"2020-12-29
06971603580296Wealy"1ml 25Gx1"""2020-12-28
06971603580302Wealy"1ml 25Gx5/8"""2020-12-28
06971603580289Wealy"1ml 27Gx1/2"""2020-12-28
06971603580340Wealy1ml 25Gx1"2020-12-28
06971603580357Wealy1ml 25Gx5/8"2020-12-28
06971603580319Wealy"3ml 23Gx1 1/4"""2020-12-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253007503MonojectCardinal Health 200, LLCPNR2026-02-19
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10192253007725MonojectCardinal Health 200, LLCPNR2026-02-19
10850053289672SurgycoSurgyco LLCPNR2025-12-11
10704411006169AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10704411007081AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10704411007104AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10827989004273Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-22
08015262020118NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262020132NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262035419NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262035488NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262039301NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
10192253010923KangarooCardinal Health 200, LLCPNR2025-02-04
10827989000091Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000107Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000114Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000121Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000138Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000145Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10192253011050KangarooCardinal Health 200, LLCPNR2024-12-02
00020451101309ENFit Syringe 1mlMedela LLCPNR2024-05-06
10192253011036KangarooCardinal Health 200, LLCPNR2024-03-25
10192253008272KangarooCardinal Health 200, LLCPNR2024-03-08
10192253008289KangarooCardinal Health 200, LLCPNR2024-03-08
16945155741457NANingbo Tianyi Medical Appliance Co., Ltd.PNR2024-02-20
16945155741464NANingbo Tianyi Medical Appliance Co., Ltd.PNR2024-02-20
16945155741471NANingbo Tianyi Medical Appliance Co., Ltd.PNR2024-02-20
16945155741488NANingbo Tianyi Medical Appliance Co., Ltd.PNR2024-02-20