FDA.reportPublic FDA data

Palmero Healthcare, LLC

Primary DI
00840415101578
Brand
Palmero Healthcare, LLC
Company
Palmero Healthcare LLC
Model
1912B
Catalog number
1912B
Device description
TUBE PROTECTOR 1200' 3"
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
NRUCHAIR, DENTAL, WITHOUT OPERATIVE UNIT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840415101578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840415101578008404151015788404151015780840415101578

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841336108554Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336110199Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-09-28
10194665008383A-decA-DEC, INC.NRU2025-09-18
D178A12H0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
D178A6E0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
06971119541316Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119541880Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119542375Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
10194665006587A-decA-DEC, INC.NRU2025-05-19
10194665006594A-decA-DEC, INC.NRU2025-05-19
08800266944368Luvis Chair (LC700C-chair only plus)DENTIS CO. ,LTDNRU2025-02-21
10194665007911A-decA-DEC, INC.NRU2025-01-24
D1355370DOME Innovation ChairDome, Inc.NRU2025-01-14
TQ26126151050Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151060Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151070Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151080Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151740Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151880Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
D06037062730DentalezDentalez Alabama, Inc.NRU2024-11-05
D0603706273PT0DentalezDentalez Alabama, Inc.NRU2024-11-05
D0603706273RW0DentalezDentalez Alabama, Inc.NRU2024-11-05
D0603706275PT0DentalezDentalez Alabama, Inc.NRU2024-11-05
10194665007324A-decA-DEC, INC.NRU2024-09-04
00304040186176EssentialsHENRY SCHEIN, INC.NRU2024-08-14
00304040186183EssentialsHENRY SCHEIN, INC.NRU2024-08-14
00810021435855DCI EdgeDCI International, LLCNRU2024-08-02
00810021435862DCI EdgeDCI International, LLCNRU2024-08-02
00810021435961DCI EdgeDCI International, LLCNRU2024-08-02
00810021435978DCI EdgeDCI International, LLCNRU2024-08-02