FDA.reportPublic FDA data

DARCO® Body Armor® Pro Term Liner

Primary DI
00609271038356
Brand
DARCO® Body Armor® Pro Term Liner
Company
DARCO INTERNATIONAL, INC.
Model
BAPTL3
Catalog number
BAPTL3
Device description
L Blue
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FZFSPLINT, EXTREMITY, INFLATABLE, EXTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZFSplint, Extremity, Inflatable, ExternalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00609271038356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00609271038356006092710383566092710383560609271038356

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable extremity splintA non-sterile sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies, e.g., accidents and motor vehicle crashes, to stabilize the limb for transport to a hospital. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184231298
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
true
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
20609271989607Aircore™ InsoleACIP0602026-01-07
20609271989614Aircore™ InsoleACIP0702026-01-07
20609271989621Aircore™ InsoleACIP0752026-01-07
20609271989638Aircore™ InsoleACIP0802026-01-07
00609271989641Aircore™ InsoleACIP0852026-01-07
20609271989652Aircore™ InsoleACIP0902026-01-07
20609271989669Aircore™ InsoleACIP0952026-01-07
20609271989676Aircore™ InsoleACIP1002026-01-07
20609271989683Aircore™ InsoleACIP1052026-01-07
20609271989690Aircore™ InsoleACIP1102026-01-07
20609271989706Aircore™ InsoleACIP1152026-01-07
20609271989713Aircore™ InsoleACIP1202026-01-07
20609271989720Aircore™ InsoleACIP1252026-01-07
20609271989737Aircore™ InsoleACIP1302026-01-07
20609271989744Aircore™ InsoleACIP1352026-01-07
20609271989751Aircore™ InsoleACIP1452026-01-07
20609271989768Aircore™ InsoleACIP1552026-01-07
00609271120167POGO™ PulsusPGP060NPGP060N2025-04-15
00609271120174POGO™ PulsusPGP070NPGP070N2025-04-15
00609271120181POGO™ PulsusPGP075NPGP075N2025-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011549505SafeSplintAPARATA MEDICAL, LLCFZF2025-09-24
24251853902854Body Armor® PFA Walker LinerDarco (Europe) GmbHFZF2025-04-15
24251853902861Body Armor® PFA Walker LinerDarco (Europe) GmbHFZF2025-04-15
04251853902874Body Armor® PFA Walker LinerDarco (Europe) GmbHFZF2025-04-15
20609271040100Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040117Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040124Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
10609271040134Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040148Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
10609271040158Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040162Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
10609271040172Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040186Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040193Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040308Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
10609271040318Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
10609271040325Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040339Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
10609271040349Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040353Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
10609271040363Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040377Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
10609271040387Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040391Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271038257DARCO® Body Armor® Pro Term LinerDARCO INTERNATIONAL, INC.FZF2023-02-08
20609271039258DARCO® Body Armor® ProTermDARCO INTERNATIONAL, INC.FZF2023-02-08
10609271039350DARCO® Body Armor® Pro TermDARCO INTERNATIONAL, INC.FZF2023-02-08
20609271809158DARCO® Night SplintDARCO INTERNATIONAL, INC.FZF2023-02-08
10609271809250DARCO® Night SplintDARCO INTERNATIONAL, INC.FZF2023-02-08
20609271809356DARCO® Night SplintDARCO INTERNATIONAL, INC.FZF2023-02-08