FDA.report

Reusable PEEP 20 valve

Primary DI
05707480029686
Brand
Reusable PEEP 20 valve
Company
Ambu A/S
Model
A000213000
Catalog number
A000213000
Device description
Ambu PEEP valve 20,range 1.5 - 20 mbar, non-calibrated, with connector, ID 30 mm (with die-stamped caution)
Published
2016-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BYEAttachment, breathing, positive end expiratory pressure

Product Code Classifications

CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480015078PackageGS140In Commercial Distribution
05707480029686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480015078057074800150785707480015078
05707480029686057074800296865707480029686

GMDN Terms

TermDefinition
PEEP valve, reusableA 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 reusable device.

Device Sizes

TypeValueUnit
Length65Millimeter
Outer Diameter45Millimeter
Weight40Gram

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+14107686464Purchase_orders@ambuUSA.com

Regulatory Flags

DUNS number
305682023
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

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