FDA.report

Andorate® Air/Water Cleaning Adapter

Primary DI
14897106950468
Brand
Andorate® Air/Water Cleaning Adapter
Company
GA Health Company Limited
Model
GAR038
Published
2020-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FFYAdaptor, Bulbs, Miscellaneous, For Endoscope

Product Code Classifications

CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14897106950468PackageGS1100In Commercial Distribution
24897106950465PackageGS1400In Commercial Distribution
04897106950461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1489710695046814897106950468
2489710695046524897106950465
04897106950461048971069504614897106950461

GMDN Terms

TermDefinition
Surgical instrument/endoscope cleaning brush/tool, single-useA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
686908512
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
14897106957887andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010492026-03-13
14897106957894andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010502026-03-13
14897106957948andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010692026-03-13
14897106957955andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010702026-03-13
14897106958013andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010952026-03-13
14897106958020andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010962026-03-13
14897106957917andorate® 4-piece valve kit1010662026-03-12
14897106958556andorate® 4-piece valve kit1010462026-03-12
14897106958587andorate® 3-piece Valve Kit1010652026-03-12
14897106958617andorate® 4-piece valve kit1010812026-03-12
14897106958624andorate® 4-piece valve kit1010922026-03-12
14897106958631andorate®Air Water Channel Cleaning Adapter + 3-piece Valve Kit1010932026-03-12
14897106958648andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit1010942026-03-12
14897106957979andorate® 3-piece Valve Kit1010872026-02-27
14897106958532andorate® 3-piece Valve Kit1010042026-02-27
14897106958549andorate® 3-piece Valve Kit1010372026-02-27
14897106957832Champion 3-piece valve kit1010042026-01-21
14897106957849Champion 3-piece valve kit1010372026-01-21
14897106957856Champion 4-piece valve kit1010462026-01-21
14897106957863Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit1010472026-01-21

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