FDA.reportPublic FDA data

N/A

Primary DI
04961333241644
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
001-007C
Device description
DEMO CASE FOR SMALL CARTS (80242)
Published
2018-03-06
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
04961333241644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333241644049613332416444961333241644

GMDN Terms#

Term, Definition table
TermDefinition
Medical capital equipment storage bag/caseA non-sterile, portable, protective container intended to be used by a healthcare provider to store/transport a piece of medical capital equipment (not included) between uses, and may in addition be intended to hold some device components during use; it is not intended to be worn by a patient to hold a personal medical device. It is a durable bag or case with a padded interior intended to prevent damage to medical devices. It is often designed to contain a specific type of device, however it does not include specific parent-device-supportive medical accessories, and is not intended to shield radiation. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854924006255C2 CryoBalloon Ablation System FG-10252025-04-04
00854924006293C2 CryoBalloon Ablation SystemFG-10292025-04-04
04961333255313C2 CryoBalloonFG-10552024-09-12
04961333255320C2 CryoBalloonFG-10562024-09-12
04961333248445C2 CryoBalloon NitroclipFG-10502020-08-07
00854924006408C2 CryoBalloon EndoGripFG-10402020-07-29
04961333232550ULTRASOUND GASTROSCOPEEG-3670URK2017-04-06
04961333232567ULTRASOUND GASTROSCOPEEG-3870UTK2017-04-06
04961333233953ULTRASOUND GASTROSCOPEEG-3270UK2017-06-26
04961333231942VIDEO PROCESSOREPK-I5010-US2018-04-16
04961333232598VIDEO PROCESSOREPK-I50102017-04-06
04961333232604VIDEO PROCESSOREPK-I70102017-04-06
04961333242207N/A92026/102018-03-08
04961333242214N/A92026/252018-03-08
04961333242221N/A92026/32018-03-08
04961333242238N/A92026/502018-03-08
04961333242276N/A92052/202018-03-08
04961333242283N/A92052/62018-03-08
04961333242306N/A92092/122018-03-08
04961333242313N/A92092/252018-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840178704702ITDTouchpoint Medical, Inc.BZN2026-05-14
00840178704658ITDTouchpoint Medical, Inc.BZN2026-05-07
06972077026419ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-05-07
06972077026426ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-05-07
G035X1BT70M0MULTIX SOLUTIONS SRLMULTIX SOLUTIONS SRLBZN2026-04-28
00840178704627ITDTouchpoint Medical, Inc.BZN2026-04-13
06972077025955ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025962ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025979ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025986ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025993ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026006ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026013ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026020ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026037ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026044ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026051ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026068ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026075ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026082ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026099ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026105ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026112ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026129ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026136ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026143ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026150ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026167ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
04056634076856symbio-cart ITD GmbHBZN2026-03-23
04056634081898symbio-cart ITD GmbHBZN2026-03-23