FDA.reportPublic FDA data

BOEHRINGER® Arm Restraint Straps ( 1 pair ) - 27 Inches

Primary DI
10816286020567
Brand
BOEHRINGER® Arm Restraint Straps ( 1 pair ) - 27 Inches
Company
BOEHRINGER LABORATORIES, LLC
Model
9008
Catalog number
9008
Device description
Arm Restraint Straps ( 1 pair ) - 27 Inches
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMQRestraint, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60816286020562PackageGS12In Commercial Distribution
10816286020567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6081628602056260816286020562
1081628602056710816286020567

GMDN Terms#

Term, Definition table
TermDefinition
Arm restraintA non-rigid device, typically a strap or band made of various materials (e.g., fabric, nylon, leather, foam), used to temporarily secure a patient's arm(s) to a fixture or furniture part (e.g., bedrail, chair, table leg) to restrict the patient's physical activity for the prevention of potential injury or hazards. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
610-278-0900info@boehringerlabs.com

Regulatory Flags#

DUNS number
079991657
Device count
1
Premarket exempt
true

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