FDA.reportPublic FDA data

RxCrush

Primary DI
00850006611027
Brand
RxCrush
Company
RESOLVE DESIGNS LLC
Model
EO05-100
Catalog number
EO05
Device description
ENFit to Oral Adapter - Large Oral Bore.Connects male ENFit (e.g. RxCrush Pouch) to male Oral syringe.
Published
2024-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYXDispenser, Liquid Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850006611024PackageGS15In Commercial Distribution
20850006611021PackageGS11000In Commercial Distribution
00850006611027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000661102410850006611024
2085000661102120850006611021
00850006611027008500066110278500066110270850006611027

GMDN Terms#

Term, Definition table
TermDefinition
ENFit/non-ISO80369-standardized linear connectorA small, non-powered, noninvasive, tubular two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at one end and a connection which is not designed according to ISO 80369 at the other end (typically barbed, conical, ENLock, threaded or non-Luer-slip), intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection typically with tubing or syringe; it does not connect a vial/bottle (i.e., not a vial/bottle adaptor). It does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of sunlight. Keep out of moisture.

Contacts#

Phone, Email table
PhoneEmail
877.343.2783info@rxcrush.com

Regulatory Flags#

DUNS number
091290281
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850006611867RxCrushCA04-100CA042025-04-30
30850006611868RxCrushCA04-100CA042025-04-30
00850006611010RxCrushPP06-50PP062024-12-17
00850006611034RxCrushPC11-ENPC112024-12-17
00850006611058RxCrushCA03-100CA032024-12-17
00850006611096RxCrushPP20-100PP202024-12-17
00850006611102RxCrushCA02-100CA022024-12-17
00850006611126RxCrushEL02-100EL022024-12-17
00850006611140RxCrushEO02-100EO022024-12-17
00850006611157RxCrushET01-100ET012024-12-17
00850006611164RxCrushPP10-50PP102024-12-17
00850006611171RxCrushEC06-50EC062024-12-17
00850006611195RxCrushPP08-50PP082024-12-17
00850006611256RxCrushPC11-REFPC112024-12-17
00850006611263RxCrushPC11-SPPC112024-12-17
00850006611300RxCrushPC11-FRPC112024-12-17
00850006611836RxCrushPC16-1PC162024-12-17
00850006611843RxCrushPP11-5PP112024-12-17
00850006611850RxCrushPP142024-12-17
30850006611011RxCrushPP06-50PP062024-12-17

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Primary DI, Brand, Company table
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10827989001333Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16