FDA.reportPublic FDA data

Vesco Medical 10F Dual Port NE Tube 36"

Primary DI
10850002550280
Brand
Vesco Medical 10F Dual Port NE Tube 36"
Company
Vesco Medical, LLC
Model
VED-29110
Device description
10Fr Dual Port NE Tube 36"
Published
2023-06-16
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
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170162000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170162000Vesco Medical Nasoenteric Feeding TubesVesco Medical, LLC2017-09-26PIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850002550280PackageGS110In Commercial Distribution
20850002550287PackageGS112In Commercial Distribution
00850002550283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000255028010850002550280
2085000255028720850002550287
00850002550283008500025502838500025502830850002550283

GMDN Terms#

Term, Definition table
TermDefinition
Nasoenteral tubeA sterile, thin, flexible, hollow cylinder designed to access the small intestines (duodenum or jejunum) through the nose and nasopharynx for examination (e.g., of intestinal contents), treatment (e.g., decompression, short-term feeding), or other purposes. It is a single- or dual-lumen, rubber or plastic tube (nasoduodenal or nasojejunal tube) that is smaller and longer than a nasogastric tube and may have a small weight or magnet at the distal tip to facilitate placement. It is frequently used for very ill or comatose patients. Some types are used to remove air and liquids from the stomach by connection to intermittent suction units and/or for enteral feeding. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French
Length36Inch

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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

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