FDA.reportPublic FDA data

Argyle

Primary DI
10884527005642
Brand
Argyle
Company
Cardinal Health, Inc.
Model
31368858
Catalog number
31368858
Device description
Baby Board Strap,Esther/Ticot
Published
2018-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSDBINDER, ABDOMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSDBinder, AbdominalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884527005642PackageGS1100In Commercial Distribution
20884527005649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452700564210884527005642
2088452700564920884527005649

GMDN Terms#

Term, Definition table
TermDefinition
Electrode/transducer strap, single-useA strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
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
10884521156159Monoject8934CRS8934CRS2017-01-06
10884521156173Monoject8985CRH8985CRH2017-01-07
20884521156200Monoject8985CRS8985CRS2017-01-07
20884521156217Monoject8989CRH8989CRH2017-01-07
10884521010444Monoject888147127388814712732018-06-30
10884521157682Curity2022A2022A2018-06-22
10884521195547Monoject1180327114E1180327114E2018-06-22
20884521195506Monoject1180323114E1180323114E2018-06-22
40884521010438Monoject888147123288814712322018-06-30
40884521018311SharpSafety8535Y8535Y2017-01-07
40884521018380Monoject8970Y8970Y2017-01-06
10884521742390Monoject888135278888813527882019-05-17
10884527006786Monoject888135278888813527882016-09-24
10884521131897VistecVS4332VS43322018-06-30
30884527004755Kendall50007363500073632016-09-24
10884521028258Kangaroo6746696746692019-11-27
10884521069343Dover888766526288876652622016-10-20
10884527010349KendallMK06860MK068602016-09-24
10884527022113Kendall3353433534-2016-09-24
10885380173691Curity6309G6309G2019-11-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00749756880428DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756880435DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756888417DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756888424DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
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