FDA.reportPublic FDA data

andorate® CO2 Source Tubing Adapter

Primary DI
04897106955862
Brand
andorate® CO2 Source Tubing Adapter
Company
GA Health Company Limited
Model
GAR108
Published
2023-08-30
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
NKCTubing/Tubing With Filter, Insufflation, Laparoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKCTubing/Tubing With Filter, Insufflation, LaparoscopicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897106955869PackageGS125In Commercial Distribution
24897106955866PackageGS14In Commercial Distribution
04897106955862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489710695586914897106955869
2489710695586624897106955866
04897106955862048971069558624897106955862

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, reusableA collection of flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a reusable device.

Regulatory Flags#

DUNS number
686908512
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897106956081andorate® ThomasTrap ™ Polyp Trap 2.0GAR1040402026-03-18
04897106958566andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit1010472026-03-18
04897106958573andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit1010482026-03-18
04897106958597andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit1010672026-03-18
04897106958603andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit1010682026-03-18
04897106957880andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010492026-03-13
04897106957897andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010502026-03-13
04897106957941andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010692026-03-13
04897106957958andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010702026-03-13
04897106958016andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010952026-03-13
04897106958023andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010962026-03-13
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
04897106957910andorate® 4-piece valve kit1010662026-03-12
04897106958559andorate® 4-piece valve kit1010462026-03-12
04897106958580andorate® 3-piece Valve Kit1010652026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493412498RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKC2026-02-16
00840493412535RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKC2026-02-16
15060120950571Insufflation FilterGVS FILTER TECHNOLOGY UK LTDNKC2025-12-11
16931918171258AllesetGRI Medical & Electronic Technology Co., Ltd.NKC2025-12-09
26931918171255AllesetGRI Medical & Electronic Technology Co., Ltd.NKC2025-12-09
30326053102791Regard™Resource Optimization & Innovation, L.L.C.NKC2025-11-21
04711605992053The O R Company - InsufflatOR Tubing SetADVANCED MEDICAL DESIGN CO., LTD.NKC2025-07-28
04048551067444NAKarl Storz GmbH & Co. KGNKC2025-03-28
04048551326664NAKarl Storz GmbH & Co. KGNKC2025-03-28
00817183020813PUREPNEUMO Tubing SetNORTHGATE TECHNOLOGIES INC.NKC2024-07-09
10817183020810PUREPNEUMO Tubing SetNORTHGATE TECHNOLOGIES INC.NKC2024-07-09
04055207070093NARichard Wolf GmbHNKC2024-05-24
04055207070109NARichard Wolf GmbHNKC2024-05-24
14897106955869andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-30
04897106955855andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-28
14897106955852andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-28
00628725007366SterisCanadian Hospital Specialties LimitedNKC2023-08-23
00628725007373SterisCanadian Hospital Specialties LimitedNKC2023-08-23
00628725007380SterisCanadian Hospital Specialties LimitedNKC2023-08-23
00628725007397SterisCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007361CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007378CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007385CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007392CHSCanadian Hospital Specialties LimitedNKC2023-08-23
30326053102784Regard™Resource Optimization & Innovation, L.L.C.NKC2023-07-28
30326053102807Regard™Resource Optimization & Innovation, L.L.C.NKC2023-07-28
30326053102814Regard™Resource Optimization & Innovation, L.L.C.NKC2023-07-28
20326053102787Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.NKC2023-07-28
20326053102800Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.NKC2023-07-28
20326053102817Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.NKC2023-07-28