FDA.reportPublic FDA data

Vesco Medical ENFit Tip Syringe

Primary DI
00850801006523
Brand
Vesco Medical ENFit Tip Syringe
Company
VESCO MEDICAL, LLC
Model
VED-620TC
Catalog number
VED-620TC
Device description
20 mL ENFit Tip Feed and Flush Syringe w/ Transition Connector
Published
2023-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K190502000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190502000ENFit Oral / Enteral SyringeJiangsu Caina Medical Co.,Ltd2019-08-06PNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850801006520PackageGS150In Commercial Distribution
20850801006527PackageGS1500In Commercial Distribution
00850801006523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085080100652010850801006520
2085080100652720850801006527
00850801006523008508010065238508010065230850801006523

GMDN Terms#

Term, Definition table
TermDefinition
ENFit oral/enteral syringe, single-useA 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 single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity40 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature60 Degrees Fahrenheit90 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit120 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
6149145991info@vescomedical.com

Regulatory Flags#

DUNS number
079527070
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810096151858Vesco Medical 1mL ENFit Low Dose Tip Syringe - Amber Bulk Non-sterileVED-601ABR2026-05-20
00810096151865Vesco Medical 3mL ENFit Low Dose Tip Syringe - Amber Bulk Non-sterileVED-603ABR2026-05-20
00810096151209Vesco MedicalVED-660RVED-660R2024-03-08
00810096151193Vesco MedicalVED-610RVED-610R2024-03-08
00810096150011Vesco Medical 12FR 91cm Adult (PU) Dual ENFit Port NG Tube VED-291122026-04-02
00810096150035Vesco Medical 16FR 91cm Adult (PU) Dual ENFit Port NG Tube VED-291162026-04-02
00810096150226Vesco Medical 8FR 91cm Adult (PU) Single ENFit Port NG Tube VED-191082026-04-02
00810096150240Vesco Medical 12FR 91cm Adult (PU) Single ENFit Port NG Tube VED-191122026-04-02
00810096150257Vesco Medical 14FR 91cm Adult (PU) Single ENFit Port NG Tube VED-191142026-04-02
00810096150905Vesco Medical 10FR 91cm Adult (PU) Single ENFit Port NG Tube VED-191102026-04-02
00850002550351Vesco Medical 6Fr 45in Dual Port ENFit NE TubeVED-214062023-06-16
00850002550368Vesco Medical 8Fr 45in Dual Port ENFit NE TubeVED-214082023-06-16
00850002550375Vesco Medical 10Fr 45in Dual Port ENFit NE TubeVED-214102023-06-16
00850801006196Vesco Medical Nasogastric Feeding TubeVED-291082023-06-26
00850002550979Vesco Medical Nasogastric Feeding TubeVED-291062023-05-25
00850002550986Vesco Medical Nasogastric Feeding TubeVED-291082023-05-25
00850801006363Vesco Medical 60mL ENFit Thumb Control SyringeVED-6612023-06-05
00850801006370Vesco Medical 60mL Thumb Control Syringe w/ 500mL ContainerVED-6652023-06-05
00810096150028Vesco Medical 14FR 91cm Adult (PU) Dual ENFit Port NG Tube VED-291142026-03-18
00810096150141Vesco Medical 12FR 114cm Adult (PU) Dual ENFit Port NG TubeVED-214122026-03-18

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Primary DI, Brand, Company table
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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
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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
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