FDA.reportPublic FDA data

MED-RX

Primary DI
00628725003917
Brand
MED-RX
Company
Canadian Hospital Specialties Limited
Model
54-1042R
Catalog number
54-1042R
Device description
"MED-RX ENTERAL FEEDING TUBE, 10 FR X 42"", PVC"
Published
2021-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPDTube, Feeding

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPDTube, FeedingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100700000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100700000MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIESBenlan, Inc.2010-12-13FPD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50628725003912PackageGS1100In Commercial Distribution
00628725003917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872500391250628725003912
00628725003917006287250039176287250039170628725003917

GMDN Terms#

Term, Definition table
TermDefinition
Nasogastric feeding tubeA sterile, thin, flexible, hollow cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily for enteral feeding and the administration of medications, either by gravity or with a pump; it may also be used for aspiration of gastric contents (e.g., gastric secretions). It is typically a single lumen, rubber or plastic tube of various diameters (typically smaller than those of nasogastric tubes intended primarily for decompression) with circular markings that serve as insertion guides. It is frequently used for very ill or comatose patients. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
905-825-9300CHS@CHSLTD.COM

Regulatory Flags#

DUNS number
240992693
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628725095295MiniMuffs0402160403412025-04-11
00628725096940Nebulizer KitMS-6920S2024-02-23
00628725097336VixOne™ Nebulizer KitR-6415VR-6415V2023-06-16
00628725097688RespanR-7420SR-7420S2023-06-22
00628725097695Pediatric Nebulizer KitR-6920SR-6920S2023-06-15
00628725097732Adult Nebulizer KitMS-6420SMS-6420S2023-06-15
00628725098173VixOne™ Nebulizer KitR-6400R-64002023-06-15
00628725098203VixOne™ Nebulizer Kit R-6405SR-6405S2024-08-20
00628725098210VixOne™ Nebulizer KitR-6415SR-6415S2023-06-15
00628725098234VixOne™ Nebulizer KitR-6420SR-6420S2023-06-15
00628725098500VixOne™ Nebulizer KitR-8420SR-8420S2023-06-15
00628725095073MISI-Medical Imaging Solutions International100301T100301T2025-09-11
00628725095080MISI-Medical Imaging Solutions International1002011002012025-09-11
00628725095103MISI-Medical Imaging Solutions International2001012001012025-09-11
00628725095165MISI-Medical Imaging Solutions International2002012002012025-09-11
00628725095172MISI-Medical Imaging Solutions International200107D200107D2025-09-11
00628725095189MISI-Medical Imaging Solutions International200101i200101i2025-09-11
00628725095196MISI-Medical Imaging Solutions International200301A200301A2025-09-11
00628725095219MISI-Medical Imaging Solutions International200105A200105A2025-09-11
50628725095078MISI-Medical Imaging Solutions International100301T100301T2025-09-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08015262022266VYGONVygon CorporationFPD2024-03-22
10680651456813HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456844HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456868HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456875HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456899HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456912HalyardAvanos Medical, Inc.FPD2018-10-04
10680651457025HalyardAvanos Medical, Inc.FPD2018-10-04
10680651457100HalyardAvanos Medical, Inc.FPD2018-10-04
10680651457179HalyardAvanos Medical, Inc.FPD2018-10-04
10817522010151Ameritus ENFitKENTEC MEDICAL, INC.FPD2018-06-04
10817522010182Ameritus ENFitKENTEC MEDICAL, INC.FPD2018-06-04
10817522010205Ameritus ENFitKENTEC MEDICAL, INC.FPD2018-06-04
10817522011554Ameritus KENTEC MEDICAL, INC.FPD2018-06-04
10817522011561Ameritus KENTEC MEDICAL, INC.FPD2018-06-04
10817522011684Ameritus KENTEC MEDICAL, INC.FPD2018-06-04
10817522011691Ameritus KENTEC MEDICAL, INC.FPD2018-06-04
10680651457513HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457544HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457568HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457582HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457605HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457629HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457650HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457681HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457704HalyardAvanos Medical, Inc.FPD2018-01-19
10680651466430HalyardAvanos Medical, Inc.FPD2018-01-19
10680651466447HalyardAvanos Medical, Inc.FPD2018-01-19