FDA.report

MEDLINE

Primary DI
20197344118448
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
HCSCUFF0041
Catalog number
HCSCUFF0041
Device description
CUFF PRESSURE REGULATOR
Published
2025-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BSKCuff, tracheal tube, inflatable

Product Code Classifications

CodeDeviceSpecialtyClass
BSKCuff, Tracheal Tube, InflatableAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344118448PackageGS110In Commercial Distribution
10197344118441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734411844820197344118448
1019734411844110197344118441

GMDN Terms

TermDefinition
Endotracheal tube cuff inflatorA manually-powered device designed to instill air into the cuff of an in situ endotracheal (ET)/endobronchial tube. The inflator typically includes a manually-operated rubber bulb for the delivery of ambient air into the cuff, and a pressure gauge or manometer that displays the pressure within the cuff to help prevent the development of excessive pressure which may cause trauma to the trachea. The purpose of the cuff is to provide an adequate seal for positive pressure ventilation and to prevent aspirated secretions from passing into the lungs. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure62 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00Keep Dry.
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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