FDA.reportPublic FDA data

Edi Catheter ENFit 6Fr/50 cm, 5pcs

Primary DI
07325710004616
Brand
Edi Catheter ENFit 6Fr/50 cm, 5pcs
Company
Maquet Critical Care AB
Model
6883899
Published
2017-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153688000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153688000Edi Catheter ENFitMaquet Critical Care AB2017-03-02PIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17325710004613PackageGS15In Commercial Distribution
07325710004616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1732571000461317325710004613
07325710004616073257100046167325710004616

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.

Regulatory Flags#

DUNS number
632707092
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07325710000632Adap etCO2 Airway Neo47217882015-10-22
07325710004180CAPNOSTAT 568820782016-01-27
07325710009796CO2 ANALYZER MODULE CAPNOSTAT 568870502018-10-09
27325710011144ITS HousingPV404668827732026-03-24
27325710011601PiCCO catheterPV2015L2068850492026-03-24
27325710017047PiCCO catheterPV2013L0768850442026-03-24
27325710017061PiCCO catheterPV2014L1668850462026-03-24
27325710017092PiCCO catheterPV2014L0868850452026-03-24
27325710017108PiCCO catheterPV2014L2268850472026-03-24
07325710011140ITS HousingPV404668827732026-03-24
07325710011607PiCCO catheterPV2015L2068850492026-03-24
07325710017043PiCCO catheterPV2013L0768850442026-03-24
07325710017067PiCCO catheterPV2014L1668850462026-03-24
07325710017098PiCCO catheterPV2014L0868850452026-03-24
07325710017104PiCCO catheterPV2014L2268850472026-03-24
07325710012642Battery module68890002025-01-19
07325710001318FLOW-i C4066774002015-10-22
07325710001349FLOW-i C2066772002015-10-18
07325710001363FLOW-i C3066773002015-10-18
07325710012673Drawer for Low mobile carts68903652023-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253012460Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012484Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012507Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012521Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253011449CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011463CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011517CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011531CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011555CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011579CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011593CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011616CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
09420012477477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480446F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
10192253007572ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007596ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007619ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007633ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007657ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007770ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007817KangarooCardinal Health 200, LLCPIF2025-04-24
10192253007879ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007954KangarooCardinal Health 200, LLCPIF2025-04-24
10192253007978KangarooCardinal Health 200, LLCPIF2025-04-24
10192253007992KangarooCardinal Health 200, LLCPIF2025-04-24