FDA.reportPublic FDA data

Palmero Healthcare, LLC

Primary DI
00840415102636
Brand
Palmero Healthcare, LLC
Company
Palmero Healthcare LLC
Model
3564
Catalog number
3564
Device description
DISCIDE ULTRA 4oz 4 OZ.
Published
2021-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRJDisinfectant, medical devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRJDisinfectant, Medical DevicesGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840415102636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840415102636008404151026368404151026360840415102636

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection agentA substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on a medical device (e.g., surgical or dental instrument) and/or facility surface; it may also contain surfactants/cleaning agents or enzymes (e.g., protease, lipase, amylase), and may in addition be intended to decalcify equipment. The medical device is intended to be exposed to the substance for a specified period to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(203)377-6424scott@jjinstruments.com

Regulatory Flags#

DUNS number
080530675
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00840415113083Palmero Healthcare20NAVY20NAVY2023-05-08
00840415113090Palmero Healthcare20GOLD20GOLD2023-05-08
00840415113106Palmero Healthcare20RED20RED2023-05-08
00840415113113Palmero Healthcare20MNAVY20MNAVY2023-05-08
00840415113120Palmero Healthcare20MGOLD20MGOLD2023-05-08
00840415113137Palmero Healthcare20MRED20MRED2023-05-08
00840415113144Palmero Healthcare20UNAVY20UNAVY2023-05-08
00840415113151Palmero Healthcare20UGOLD20UGOLD2023-05-08
00840415113168Palmero Healthcare20URED20URED2023-05-08
00840415113175Palmero Healthcare34NAVY34NAVY2023-05-08
00840415113182Palmero Healthcare34GOLD34GOLD2023-05-08
00840415113199Palmero Healthcare34RED34RED2023-05-08
00840415113205Palmero Healthcare34MNAVY34MNAVY2023-05-08
00840415113212Palmero Healthcare34MGOLD34MGOLD2023-05-08
00840415113229Palmero Healthcare34MRED34MRED2023-05-08
00840415113236Palmero Healthcare34UNAVY34UNAVY2023-05-08
00840415113243Palmero Healthcare34UGOLD34UGOLD2023-05-08
00840415113250Palmero Healthcare34URED34URED2023-05-08
00840415113267Palmero Healthcare23BLACK23BLACK2023-05-08
00840415113274Palmero Healthcare23FORESTGREEN23FORESTGREEN2023-05-08

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