FDA.reportPublic FDA data

The O R Company - InsufflatOR Tubing Set

Primary DI
04711605992053
Brand
The O R Company - InsufflatOR Tubing Set
Company
ADVANCED MEDICAL DESIGN CO., LTD.
Model
PFITF-10
Published
2025-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
04711605992060PackageGS110In Commercial Distribution
04711605992077PackageGS160In Commercial Distribution
04711605992053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04711605992060047116059920604711605992060
04711605992077047116059920774711605992077
04711605992053047116059920534711605992053

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of flexible tubing intended to channel 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; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656305567
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
04711605991643The OR Company-InsufflatOR NeedleIN-12-42016-09-21
04711605991667The OR Company-InsufflatOR NeedleIN-12-42016-09-21
04711605991674The OR Company-InsufflatOR NeedleIN-15-42016-12-10

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
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
04897106955862andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-30
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