FDA.report

Medline

Primary DI
20884389976071
Company
MEDLINE INDUSTRIES, INC.
Model
MDS9911HPS
Catalog number
MDS9911HPS
Device description
CUFF, BP, DISP, 1T, SM CHLD, HP
Published
2022-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
20884389976071PackageGS15In Commercial Distribution
10884389976074PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
20884389976071PackageGS15BAG10884389976074In Commercial Distribution
10884389976074PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
DXQBlood Pressure Cuff2Cardiovascular870.1120NEligible

Premarket Submissions

SubmissionSupplement
K161035000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K161035000Medline Singe Patient Use Blood Pressure CuffMedline Industries, Inc.2016-06-13DXQ

GMDN Terms

TermDefinition
Blood pressure cuff, single-useA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is typically wrapped around the upper arm of the patient. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

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

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