FDA.reportPublic FDA data

Wealy

Primary DI
06971603585239
Brand
Wealy
Company
Shantou Wealy Medical Instrument Co., Ltd.
Model
60ml
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
2022-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KCPSyringe, Ent
PNREnteral Syringes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCPSyringe, EntEar, Nose, Throat1
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
06971603585239PackageGS160In Commercial Distribution
06971603585246PackageGS14In Commercial Distribution
06971603585222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971603585239069716035852396971603585239
06971603585246069716035852466971603585246
06971603585222069716035852226971603585222

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545570186
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971603585192Wealy20ml2022-12-13
06971603585222Wealy60ml2022-10-13
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
10192253007435MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007503MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007541MonojectCardinal Health 200, LLCPNR2026-02-19
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