FDA.reportPublic FDA data

RxCrush

Primary DI
20850006611144
Brand
RxCrush
Company
RESOLVE DESIGNS LLC
Model
EO02-100
Catalog number
EO02
Device description
ENFit to Oral Adapter - Standard. 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
Rx
false
OTC
true
Sterile
false
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
10850006611147PackageGS15In Commercial Distribution
20850006611144PackageGS11000In Commercial Distribution
00850006611140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000661114710850006611147
2085000661114420850006611144
00850006611140008500066111408500066111400850006611140

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877.343.2783info@rxcrush.com

Regulatory Flags#

DUNS number
091290281
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850006611867RxCrushCA04-100CA042025-04-30
30850006611868RxCrushCA04-100CA042025-04-30
00850006611010RxCrushPP06-50PP062024-12-17
00850006611027RxCrushEO05-100EO052024-12-17
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840330702765ProCureTwin Med, LLCKYX2026-07-08
00827989008175Topi-CLICKHealth Care Logistics, Inc.KYX2026-06-15
18859299184705SMARTeZ Fluid Transfer SetEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKYX2026-04-08
08809692500285Dr.INVIVOROKIT HEALTHCARE Inc.KYX2026-04-02
00008279897857Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
30827989000354Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-09-16
10827989003924Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003931Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003948Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003955Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989000381Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989000404Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989003429Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989003801Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-20
10827989000398Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-03
10827989004167Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-03
10827989000336Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000343Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000350Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000770Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004044Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004051Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004068Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989001098Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001128Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001159Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001180Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001210Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001241Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001272Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16