FDA.reportPublic FDA data

NC1S50SE-YM

Primary DI
10816336022008
Brand
NC1S50SE-YM
Company
NEOCHILD, LLC
Model
NC1S50SE-YM
Device description
Feeding Tube 5fr x 40cm - Silicone
Published
2019-03-01
Public version status
New
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
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082710000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082710000SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SETNeochild, LLC2009-01-23KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816336022005PackageGS110In Commercial Distribution
10816336022008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081633602200520816336022005
1081633602200810816336022008

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
(888)887-6428info@neochild.com

Regulatory Flags#

DUNS number
022760922
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
01081633602518WUSA6010WUSA60102026-10-08
10816336022275NC600300-ENFNC600300-ENF2026-07-23
10816336022282NC602000-ENFNC602000-ENF2026-07-23
10816336022442NC600100-ENFNC600100-ENF2026-07-23
00108163360204NeoChildNeoChildNC2000022025-03-04
20816336020346NC200002NC2000022025-05-08
20816336020353NC200002NC2000022025-05-08
20816336020858NeoChildNeoChildNC2000022025-03-04
10816336020004IS60ENOCIS60ENOC2024-06-12
10816336020301NC40100TNC40100T2018-02-19
10816336022121NC70000TNC70000T2019-03-01
10816336020936NC40100TNC40100T2018-02-19
10816336020318NC40150TNC40150T2018-02-19
10816336020998KMI-UACTRAYHKMI-UACTRAYH2024-07-15
20816336020971KMI-UACTRAYHKMI-UACTRAYH2024-07-15
02081633602005IS60ENOCIS60ENOC2024-06-12
10816336022732NC23000TNC23000T2024-03-24
20816336022739NC23000TNC23000T2024-03-24
10816336022381NC1P65SE-ENFNC1P65SE-ENF2024-01-11
20816336022388NC1P65SE-ENFNC1P65SE-ENF2024-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00350770997797MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTWAvanos Medical, Inc.KNT2026-10-20
00350770997834MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
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