FDA.reportPublic FDA data

Argyle

Primary DI
10192253021110
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
MI00775
Catalog number
MI00775
Device description
Argyle I.V. Baby Support Board
Published
2021-02-15
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
50192253021118PackageGS150In Commercial Distribution
10192253021110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225302111850192253021118
1019225302111010192253021110

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
Length9.8Centimeter
Width4.1Centimeter

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
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014655944MedtronicQuantum Ops, Inc.BTX2025-12-19
10192253021134ArgyleCardinal Health 200, LLCBTX2021-02-15
50192253021118ArgyleCardinal Health 200, LLCBTX2021-02-15
50192253021132ArgyleCardinal Health 200, LLCBTX2021-02-15
10192253021127ArgyleCardinal Health 200, LLCBTX2021-02-10
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