FDA.reportPublic FDA data

N/A

Primary DI
04961333242078
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
80225-2
Device description
COMPACT CART (HUI)
Published
2018-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333242078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333242078049613332420784961333242078

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope transport trolleyA cart that is specially designed with dedicated instrument trays for the protective transport and short-term storage of endoscopes, their accessories, and other sensitive equipment. This trolley (cart) typically consists of a metal frame with plastic panels, and contains various numbers of platforms (e.g., trays that slot into the frame). It provides a safe and efficient environment for the organization of the endoscopes, minimizing their direct handling and contact with airborne contaminants, and allowing their visualization to distinguish those that have been sterilized from those that are contaminated.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth26Inch
Height45.5Inch
Width24.5Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333225262DEFINAEPK-3000-US2018-04-16
04961333230594N/A9122D2017-04-06
04961333232154VIDEO BRONCHOSCOPEEB-1170K2017-04-06
04961333232161VIDEO BRONCHOSCOPEEB-1570K2017-04-06
04961333232178VIDEO BRONCHOSCOPEEB-1575K2017-04-06
04961333232185VIDEO BRONCHOSCOPEEB-1970K2017-04-06
04961333232192VIDEO BRONCHOSCOPEEB-1970TK2017-04-06
04961333232208ULTRASOUND BRONCHOSCOPEEB-1970UK2017-04-06
04961333232215VIDEO BRONCHOSCOPEEB-1975K2017-04-06
04961333232222VIDEO BRONCHOSCOPEEB-1990I2017-04-06
04961333232239VIDEO COLONOSCOPEEC-2990LI2017-04-06
04961333232253VIDEO COLONOSCOPEEC-3490LI2017-04-06
04961333232260VIDEO COLONOSCOPEEC-3490LK2017-04-06
04961333232277VIDEO COLONOSCOPEEC-3490TLI2017-04-06
04961333232284VIDEO COLONOSCOPEEC34-I10L2017-04-06
04961333232345VIDEO COLONOSCOPEEC-3890LI2017-04-06
04961333232352VIDEO COLONOSCOPEEC-3890LK2017-04-06
04961333232369VIDEO COLONOSCOPEEC-3890LZI2017-04-06
04961333232376VIDEO COLONOSCOPEEC-3890TLK2017-04-06
04961333232383VIDEO COLONOSCOPEEC38-I10L2017-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840178704955ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704962ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704979ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704986ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704993ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705006ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705013ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705020ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705037ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705044ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705051ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705068ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705075ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705082ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705099ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705105ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705112ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705129ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705136ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705143ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705150ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705167ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705174ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705181ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705198ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705204ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705211ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705235ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704863ITDTouchpoint Medical, Inc.BZN2026-08-03
00840178704122ITDTouchpoint Medical, Inc.BZN2026-07-07