FDA.reportPublic FDA data

Argyle

Primary DI
50192253021118
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956101524CARDINAL HEALTHSOP73TKAPBSOP73TKAPB2026-06-03
10198956177055CARDINAL HEALTHPBCGPVWTIPBCGPVWTI2026-06-03
10198956198456CARDINAL HEALTHSMA69OMBFFSMA69OMBFF2026-06-03
10198956309012CARDINAL HEALTHMAT534227DMAT534227D2026-06-03
10198956320086CARDINAL HEALTHSOP73HESJESOP73HESJE2026-06-03
10198956320123CARDINAL HEALTHPV63ADSTIPV63ADSTI2026-06-03
10198956328938CARDINAL HEALTHSCV3ICVJCDSCV3ICVJCD2026-06-03
10198956332638CARDINAL HEALTHSOP52AC52ASOP52AC52A2026-06-03
10198956334915CARDINAL HEALTHSANCGCARIFSANCGCARIF2026-06-03
10198956346369CARDINAL HEALTHSCVCGEPSBBSCVCGEPSBB2026-06-03
10198956348950CARDINAL HEALTHSBA4LMNGRESBA4LMNGRE2026-06-03
10198956362147CARDINAL HEALTHSOP73KPIODSOP73KPIOD2026-06-03
10198956363922CARDINAL HEALTHSEN41FPVVDSEN41FPVVD2026-06-03
10198956371040CARDINAL HEALTHSOP56KAOSHSOP56KAOSH2026-06-03
10198956372641CARDINAL HEALTHSOP43ARANBSOP43ARANB2026-06-03
10198956379008CARDINAL HEALTHSOP45CAGHISOP45CAGHI2026-06-03
10198956385689CARDINAL HEALTHSOP44TKSVCSOP44TKSVC2026-06-03
10198956386099CARDINAL HEALTHSMA56IVRCBSMA56IVRCB2026-06-03
10198956390928CARDINAL HEALTHSBA54LCTCCSBA54LCTCC2026-06-03
10198956391437CARDINAL HEALTHSOT42SPMSESOT42SPMSE2026-06-03

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
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