FDA.reportPublic FDA data

NA

Primary DI
00859950007481
Brand
NA
Company
FOOTPRINT MEDICAL, INC.
Model
P1FTS8.0-EN
Device description
Polyurethane Feeding Tube with male Enteral Connector 8.0Fr by 40cm
Published
2022-09-29
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
K102548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102548000FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBEFootprint Medical, Inc.2010-11-26KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859950007488PackageGS110In Commercial Distribution
00859950007481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085995000748810859950007488
00859950007481008599500074818599500074810859950007481

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 Gauge8French
Length40Centimeter

Contacts#

Phone, Email table
PhoneEmail
2102262600info@footprintmed.com

Regulatory Flags#

DUNS number
791238046
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
00858778006867N/AP1PIC1.4-STY2025-06-26
00858778006874N/AP1PIC1.9-STY2025-06-26
00858778006881N/AP2PIC1.9-STY2025-06-26
00858778006850N/APROBE-UMB2024-03-28
00858778006003NASHEATH1.42016-09-19
00858778006010NASHEATH1.92016-09-20
00859950007450NAP1FTS4.0-EN2022-09-29
00859950007467NAP1FTS5.0-EN2022-09-29
00859950007474NAP1FTS6.5-EN2022-09-29
00859950007498NAP1FTM4.0-EN2022-09-29
00859950007504NAP1FTM5.0-EN2022-09-29
00859950007511NAP1FTM6.5-EN2022-09-29
00859950007528NAP1FTM8.0-EN2022-09-29
00859950007535NAP1FTL5.0-EN2022-09-29
00859950007542NAP1FTL6.5-EN2022-09-29
00859950007559NAP1FTL8.0-EN2022-09-29
00859950007566NAP1FTL10.0-EN2022-09-29
00859950007573NAS1FTS5.0-EN2022-09-29
00859950007580NAS1FTS6.5-EN2022-09-29
00859950007597NAS1FTS8.0-EN2022-09-29

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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