FDA.reportPublic FDA data

Argyle

Primary DI
10192253021127
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
MI00850
Catalog number
MI00850-
Device description
Argyle I.V. Support Board
Published
2021-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTXBOARD, ARM (WITH COVER), STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTXBoard, Arm (With Cover), SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253021125PackageGS150In Commercial Distribution
10192253021127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225302112550192253021125
1019225302112710192253021127

GMDN Terms#

Term, Definition table
TermDefinition
Arm procedure positioner, reusableA preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12.4Centimeter
Width4.8Centimeter

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014655944MedtronicQuantum Ops, Inc.BTX2025-12-19
10192253021110ArgyleCardinal Health 200, LLCBTX2021-02-15
10192253021134ArgyleCardinal Health 200, LLCBTX2021-02-15
50192253021118ArgyleCardinal Health 200, LLCBTX2021-02-15
50192253021132ArgyleCardinal Health 200, LLCBTX2021-02-15
50192253021125ArgyleCardinal Health 200, LLCBTX2021-02-10
10884527006458ArgyleCardinal Health, Inc.BTX2018-06-30
10884527006472ArgyleCardinal Health, Inc.BTX2018-06-30
30884527006452ArgyleCardinal Health, Inc.BTX2018-06-30
30884527006476ArgyleCardinal Health, Inc.BTX2018-06-30
10884527006465ArgyleCardinal Health, Inc.BTX2018-06-27
30884527006469ArgyleCardinal Health, Inc.BTX2018-06-27
00811304020553Voss Laminectomy HarnessVM/POSITIONING, INC.BTX2018-06-11
00058582006359ADVOCATE ORAL & RECTAL THERMOMETERDIABETIC SUPPLY OF SUNCOAST, INC.BTX2017-02-06