FDA.report

DRIVEMEDICAL

Primary DI
50822383989186
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
13009BV-CL
Device description
Patient RoomTrapezes Product Description: Trapeze Clamp,Brown Vein,2-PC/bx
Published
2019-06-21
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
false

Related Records

Product Codes

CodeName
IKXAID, TRANSFER

Product Code Classifications

CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50822383989186PackageGS18In Commercial Distribution
00822383989181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5082238398918650822383989186
00822383989181008223839891818223839891810822383989181

GMDN Terms

TermDefinition
Trapeze bar exerciserA full-body exercise apparatus designed to improve the range of motion around the joints by stretching the major muscle groups in the body using bars. It may consist of short moveable bars that hang from springs supported by a metal frame installed on a horizontal table, or of trapezoid-like steel bars that hang from chains supported by a metal frame attached to a bed; both assist in stretching exercises of the upper limbs, trunk, and lower limbs, and also help users to change position in bed. The device is mainly intended to improve the flexibility of muscles; it can also increase muscle strength, balance, and coordination, and/or increase cardiovascular endurance.

Sterilization Methods

Method

Regulatory Flags

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

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