FDA.reportPublic FDA data

Vesco Medical 5mL ENFit Tip Syringe

Primary DI
10850801006704
Brand
Vesco Medical 5mL ENFit Tip Syringe
Company
Vesco Medical, LLC
Model
VED-605B
Device description
5mL ENFit Tip Syringe Pharmacy Bulk Pack
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10850801006704PackageGS1500In Commercial Distribution
20850801006701PackageGS14In Commercial Distribution
00850801006707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085080100670410850801006704
2085080100670120850801006701
00850801006707008508010067078508010067070850801006707

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 Volume5Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6149145991info@vescomedical.com

Regulatory Flags#

DUNS number
119007223
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
false
Expiration date on label
false
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
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

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