FDA.reportPublic FDA data

Curaplex

Primary DI
00815277028110
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
14757MS
Device description
Curaplex Nasogastric Tube, 10Fr 280ea/cs
Published
2016-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277028110PackageGS1280In Commercial Distribution
00815277023160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277028110008152770281108152770281100815277028110
00815277023160008152770231608152770231600815277023160

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
070556204
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094575809Curaplex680152-KIT680152-KIT2023-04-30
00815277028059Curaplex8600-ATFMLOK2016-12-14
00815277029377Curaplex680150-KIT680150-KIT2018-12-15
01999720000003Curaplex Advanced Hemostatic Gauze4in x 4in(10cm x 10cm)CAHG-4X42025-11-25
01999720000027Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-11-25
01999720000041Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-11-25
01999720000065Curaplex®8600-015558600-015552025-11-13
01999720000263Curaplex670070-KIT670070-KIT2025-11-25
00810071638619CURAPLEXS1137301-S11372023-03-30
00817617023052Curaplex3141-910103141-910102017-09-04
00817617023069Curaplex3141-910123141-910122017-09-04
00817617023083Curaplex3141-910143141-910142017-09-04
00817617023335Curaplex36111361112017-09-04
00199972000085Curaplex8600-015358600-015352026-01-23
00199972000092Curaplex8600-015368600-015362026-01-23
00199972000108Curaplex8600-015378600-015372026-01-23
00199972000115Curaplex8600-015388600-015382026-01-23
00199972000122Curaplex8600-015398600-015392026-01-23
00199972000139Curaplex8600-015408600-015402026-01-23
00199972000146Curaplex8600-015418600-015412026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253011449CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
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10192253011487CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
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10192253011128KangarooCardinal Health 200, LLCKNT2025-05-28
10192253011159CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011173CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
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10192253011104KangarooCardinal Health 200, LLCKNT2025-01-14
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G461EGCT40M0EndolumikEndolumik, Inc.KNT2024-08-06
10192253011319KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011326KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011333KangarooCardinal Health 200, LLCKNT2024-06-13