FDA.report

Medline

Primary DI
20080196738714
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS9505LF
Catalog number
MDS9505LF
Device description
BLADDER,BAG,BP,2 TUBE, ADULT, LF
Published
2016-10-14
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
false

Related Records

Contact Domains

Product Codes

CodeName
DXQblood pressure cuff

Product Code Classifications

CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20080196738714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2008019673871420080196738714

GMDN Terms

TermDefinition
Blood pressure cuff inflator, manualA bulb-like device intended to be used to manually inflate the cuff of a manual sphygmomanometer. It is connected to one of the connectors of the cuff and the operator manually pumps air into the cuff by continually squeezing this device until the desired pressure within the cuff has been reached. It will typically consist of a rubber bulb, a one-way valve that draws in ambient air, and a release valve used by the operator to slowly release the pressure in the complete sphygmomanometer/cuff/inflator system so that blood pressure can be measured. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
false
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
true
Sterilization required before use
false

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