EM

Primary DI
30026072001470
Brand
EM
Company
Allied Medical, LLC
Model
LPEEP
Device description
PEEP VALVE 12/CS
Published
2024-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K882219000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K882219000P.E.E.P. VALVELife Support Products, Inc.1988-08-30BYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30026072001470PackageGS112In Commercial Distribution
00026072001479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3002607200147030026072001470
00026072001479000260720014790260720014790026072001479

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119066872
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00026072021439PC11-20-00112024-09-17
00026072026861ALLIED MEDICAL LLC01-90-310001-90-31002025-10-13
00026072026878ALLIED MEDICAL LLC01-90-3100-KIT01-90-3100-KIT2025-10-13
00026072026892ALLIED MEDICAL LLC01-90-392801-90-39282025-10-13
00026072026908ALLIED MEDICAL LLC01-90-3928-KIT 01-90-3928-KIT 2025-10-13
00026072001479EMLPEEP2024-05-28
00026072012161BF645502024-05-28
00026072020548BF64095-AHP2024-10-11
00026072022177EML599-0102024-05-28
00026072022184EML599-0302024-05-28
00026072022191EML599-1302024-05-28
00026072022207EML599-1402024-05-28
00026072022214EML599-1802024-05-28
00026072022238EML599-1902024-05-28
00026072022252EML599-2802024-05-28
00026072022924BF338002024-10-11
00026072022931BF338012024-05-28
00026072023006BF332072024-10-11
00026072023013BF640072024-10-11
00026072023037BF640412024-05-28

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00026072001479EMAllied Medical, LLCBYE2024-05-28
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