FDA.reportPublic FDA data

Palmero Healthcare, LLC

Primary DI
00840415101639
Brand
Palmero Healthcare, LLC
Company
Palmero Healthcare LLC
Model
1949
Catalog number
1949
Device description
SYRINGE TIP COVERS (250) 250 PER BAG
Published
2021-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECBUNIT, SYRINGE, AIR AND/OR WATER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840415101639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840415101639008404151016398404151016390840415101639

GMDN Terms#

Term, Definition table
TermDefinition
Device lumen washing/disinfection attachment, single-useA device intended to be fitted to a luminal device (e.g., catheter, endoscope air/water channel, vitrectomy handpiece) to assist with the washing and/or disinfection of the lumen of the device during a medical/surgical procedure and/or for maintenance pre/post procedure. It is typically in the form of a small, cylindrical rod(s) which may have a button/switch which controls the supply of air and/or water; it may also include tubing and/or be used in conjunction with a syringe, device washer/disinfector, and/or water tap. This is a single-use device.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840415100144Palmero Healthcare, LLC1915A1915A2021-03-07
00840415101646Palmero Healthcare, LLC197019702021-03-05
00840415101653Palmero Healthcare, LLC197119712021-03-06
00840415100069Palmero Healthcare, LLC1803B1803B2021-03-04
00840415100076Palmero Healthcare, LLC1803C1803C2021-03-04
00840415100083Palmero Healthcare, LLC1803CP1803CP2021-03-04
00840415100090Palmero Healthcare, LLC1803M1803M2021-03-04
00840415100113Palmero Healthcare, LLC185018502021-03-04
00840415100120Palmero Healthcare, LLC1850S1850S2021-03-04
00840415100137Palmero Healthcare, LLC191519152021-03-04
00840415100243Palmero Healthcare, LLC1918A1918A2021-03-04
00840415100298Palmero Healthcare, LLC1865C1865C2021-03-04
00840415100304Palmero Healthcare, LLC1866C1866C2021-03-04
00840415100311Palmero Healthcare, LLC1867C1867C2021-03-04
00840415100328Palmero Healthcare, LLC190219022021-03-04
00840415100335Palmero Healthcare, LLC190119012021-03-04
00840415100342Palmero Healthcare, LLC191019102021-03-04
00840415100359Palmero Healthcare, LLC191419142021-03-04
00840415100366Palmero Healthcare, LLC1918B1918B2021-03-04
00840415101561Palmero Healthcare, LLC191219122021-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30810021439403DCIDCI International, LLCECB2025-11-19
00840326423677AstekYoung Innovations, Inc.ECB2025-02-07
TQ26SYT253721Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.ECB2024-12-09
D248B16201DurationHAGER WORLDWIDE, INC.ECB2024-05-20
D248B16211DurationHAGER WORLDWIDE, INC.ECB2024-05-20
D248B1629C1Uni-TipHAGER WORLDWIDE, INC.ECB2024-05-20
00810339031176SAFE DENTBGSS Company Inc.ECB2024-05-01
00810339031251SAFE DENTBGSS Company Inc.ECB2024-05-01
00810339031374SAFE DENTBGSS Company Inc.ECB2024-05-01
00854014003577SAFE DENTBGSS Company Inc.ECB2024-05-01
00854014003607SAFE DENTBGSS Company Inc.ECB2024-05-01
00840326421994AstekYoung Innovations, Inc.ECB2023-12-01
00840326422007AstekYoung Innovations, Inc.ECB2023-12-01
00840326422014AstekYoung Innovations, Inc.ECB2023-12-01
00840326422021AstekYoung Innovations, Inc.ECB2023-12-01
00840326422045AstekYoung Innovations, Inc.ECB2023-12-01
00840326422052AstekYoung Innovations, Inc.ECB2023-12-01
00840326422069AstekYoung Innovations, Inc.ECB2023-12-01
00840326422076AstekYoung Innovations, Inc.ECB2023-12-01
00840326422083AstekYoung Innovations, Inc.ECB2023-12-01
00840326422090AstekYoung Innovations, Inc.ECB2023-12-01
00840326422106AstekYoung Innovations, Inc.ECB2023-12-01
00840326422113AstekYoung Innovations, Inc.ECB2023-12-01
D248B16291Uni-Tip -Package of 3HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16311Access-Tips -Package of 3HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16331Uni-Tip -Package of 100HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16341Access-Tips -Package of 100HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16351Uni-Tip -Package of 25HAGER WORLDWIDE, INC.ECB2023-09-12
D248B16361Access-Tips -Package of 25HAGER WORLDWIDE, INC.ECB2023-09-12
D248BOA124P10001Uni-Tip -Package of 5HAGER WORLDWIDE, INC.ECB2023-09-12