FDA.reportPublic FDA data

Azure

Primary DI
00643293028896
Brand
Azure
Company
TRULIFE LIMITED
Model
AZ400G
Device description
Azure Leg Protector
Published
2023-02-10
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

Product Codes#

Code, Name table
CodeName
JZRSUPPORT GELS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZRSupport GelsImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643293028896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643293028896006432930288966432930288960643293028896

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient pressure distribution pad, reusableA cushion (e.g., gel-filled, foam) intended to be placed between an operating table mattress or a patient positioner (e.g., torso intraoperative positioner, perineal post) and the patient to distribute the patient's body weight over a large surface area, for the prevention of pressure sores and tissue necrosis on prominent parts of the patient's body when immobilized for extended periods during surgery. It is available in various dimensions and shapes to accommodate various body parts such as the buttocks, shoulders, heels, or the entire body (usually excluding the head). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985048669
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
00645517899350TrulifeTN250-22026-02-17
00645517899367TrulifeTN250-32026-02-17
00645517899374TrulifeTN250-42026-02-17
00645517899381TrulifeTN250-52026-02-17
00645517872773TrulifeSSF400-27-L-2 2025-09-19
00645517872780TrulifeSSF400-27-L-3 2025-09-19
00645517872827TrulifeSSF400-28-L-1 2025-09-19
00645517872834TrulifeSSF400-28-L-2 2025-09-19
00645517872872TrulifeSSF400-28-R-3 2025-09-19
00645517872889TrulifeSSF400-29-L-2 2025-09-19
00645517872933TrulifeSSF400-30-R-3 2025-09-19
00645517872988TrulifeSSF403-23-R-1 2025-09-19
00645517873039TrulifeSSF403-24-R-1 2025-09-19
00645517873084TrulifeSSF403-25-L-3 2025-09-19
00645517873138TrulifeSSF403-26-L-2 2025-09-19
00645517873183TrulifeSSF403-27-L-1 2025-09-19
00645517873190TrulifeSSF403-27-L-2 2025-09-19
00645517873237TrulifeSSF403-27-R-3 2025-09-19
00645517873244TrulifeSSF403-28-L-1 2025-09-19
00645517873282TrulifeSSF403-28-R-2 2025-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
26952534431011SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.JZR2023-04-06
26952534431028SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.JZR2023-04-06
26952534431035SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.JZR2023-04-06
00643293028858AzureTRULIFE LIMITEDJZR2023-02-10
00643293028865AzureTRULIFE LIMITEDJZR2023-02-10
00643293028872AzureTRULIFE LIMITEDJZR2023-02-10
00643293028889AzureTRULIFE LIMITEDJZR2023-02-10
00643293028902AzureTRULIFE LIMITEDJZR2023-02-10
00643293028919Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028926Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028933Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028940Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028957Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028964Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028971Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028988Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293028995Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293029008Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293029015Oasis EliteTRULIFE LIMITEDJZR2023-02-10
00643293029022EliteTRULIFE LIMITEDJZR2023-02-10
00643293029039EliteTRULIFE LIMITEDJZR2023-02-10
00643293029046OasisTRULIFE LIMITEDJZR2023-02-10
00643293029053OasisTRULIFE LIMITEDJZR2023-02-10
00643293029060OasisTRULIFE LIMITEDJZR2023-02-10
00643293029077OasisTRULIFE LIMITEDJZR2023-02-10
00643293029084OasisTRULIFE LIMITEDJZR2023-02-10
00643293029091OasisTRULIFE LIMITEDJZR2023-02-10
00643293029107OasisTRULIFE LIMITEDJZR2023-02-10
00643293029114OasisTRULIFE LIMITEDJZR2023-02-10
00643293029121OasisTRULIFE LIMITEDJZR2023-02-10