Sunmed

Primary DI
10889483039038
Brand
Sunmed
Company
SUNMED, LLC
Model
8-6002-30
Device description
PEEP VALVE 5-20cm 30mm ID X 33mm OD
Published
2016-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYEAttachment, Breathing, Positive End Expiratory Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053466000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053466000HSINER RESUSCITATORHsiner Co., Ltd.2006-03-22BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889483039038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088948303903810889483039038

GMDN Terms#

Term, Definition table
TermDefinition
PEEP valve, single-useA non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter30Millimeter
Outer Diameter33Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature. Do not get wet.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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