FDA.reportPublic FDA data

DeRoyal

Primary DI
08682952418144
Brand
DeRoyal
Company
PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI
Model
71-2722
Device description
Suction Liner Wal Hanger Adapter (Type-2)
Published
2025-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
PROAnti-Regurgitation Blood Tubing Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2
PROAnti-Regurgitation Blood Tubing KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08682952418144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08682952418144086829524181448682952418144

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation system canister/bottle holder, single-useA device intended to be used to hold a dedicated fluid or collection/specimen canister or bottle that is used within a suction and/or irrigation system. This device can be used to mount the canister/bottle(s) to the parent system when it is mobile (on wheels), or to mount the canister/bottle to a medical device service rail system or a wall rail (typically used on the ward). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533130347
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08681756013401Pergo05TD13702025-12-26
08682952400545Pergo05TD360505TD36052025-12-26
08681756013425Pergo05TD13702025-12-26
08682952400569Pergo05TD360505TD36052025-12-26
08682952411039PergoSC0405CVL2023-12-06
08682952420093DeRoyal71-00462025-11-06
08682952411053PergoSC0405XVTC2023-12-06
08682952411121PergoSC0405CVT2023-12-06
08682952410995PergoSC0405WHA2023-12-06
08682952411107PergoSC0405ST2023-12-06
08682952413750CMR201022025-08-20
08682952413774CMR202012025-08-20
08682952413798CMR203022025-08-20
08682952413811CMR204012025-08-20
08682952413835CMR205012025-08-20
08682952413859CMR209022025-08-20
08682952419370DeRoyal71-BG1000-PE2025-07-30
08682952419394DeRoyal71-BG1500-PE2025-07-30
08682952419417DeRoyal71-BG2000-PE2025-07-30
08682952419431DeRoyal71-BG3000-PE2025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956534681CARDINAL HEALTHCardinal Health 200, LLCGCX2026-07-27
10192253043365CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043372CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043389CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043396CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043402CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043419CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
08682952420093DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-11-06
00848530084011Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-06-18
00848530099640Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCX2025-05-21
00848530103996Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-14
00848530104009Oxygen Wrench and Washer KitSunset Healthcare Solutions, Inc.GCX2025-05-14
00848530105464Washer with Rubber Ring - AluminumSunset Healthcare Solutions, Inc.GCX2025-05-14
08682952418014PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-13
00848530105747Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105754Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105723Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105730Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
08682952417437DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
08682952417451DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
08682952417482DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
10192253041736ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253041743ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253041750ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253038965ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038972ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038989ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038996ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253003017Aqua-SealCardinal Health 200, LLCGCX2025-02-18
10192253003024Aqua-SealCardinal Health 200, LLCGCX2025-02-18