FDA.report

RUSCH

Primary DI
34026704662594
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN029672
Catalog number
157200190
Device description
PEEP VALVE 22MM 10/BX
Published
2019-07-24
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
true

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
34026704662594PackageGS110In Commercial Distribution
04026704541911PreviousGS10
14026704662590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670466259434026704662594
04026704541911040267045419114026704541911
1402670466259014026704662590

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in clean dry conditions away from heat and light.
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
44710810117464N/AGALEMED CORPORATIONBYE2026-03-05
00856825003159N/AGALEMED CORPORATIONBYE2026-03-04
00856825003166N/AGALEMED CORPORATIONBYE2026-03-04
00856825003197N/AGALEMED CORPORATIONBYE2026-03-04
00856825003203N/AGALEMED CORPORATIONBYE2026-03-04
00850071887297Emergent RespiratoryMDL Solutions IncorporatedBYE2026-02-11
07045432116083The BAG PEEP Valve 2-10 cmH2OLaerdal Medical ASBYE2026-01-14
07045432116090The BAG PEEP Valve 5-20 cmH2OLaerdal Medical ASBYE2026-01-14
10889483228708WaterPAP™SUNMED, LLCBYE2025-12-15
10889483228715WaterPAP™SUNMED, LLCBYE2025-12-15
10889483270554AirLife™SUNMED, LLCBYE2025-12-15
00810094578541Curaplex®BOUND TREE MEDICAL, LLCBYE2025-08-06
00810094579234Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094578558Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094579210Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094579227Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094579272Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
10841470100145O2-MAXPULMODYNE INCBYE2025-04-12
10841470111486Go-PAPPULMODYNE INCBYE2025-04-12
10841470111493Go-PAPPULMODYNE INCBYE2025-04-12
10841470111509Go-PAPPULMODYNE INCBYE2025-04-12
10841470111516Go-PAPPULMODYNE INCBYE2025-04-12
10841470111592Go-PAPPULMODYNE INCBYE2025-04-12
10841470111608Go-PAPPULMODYNE INCBYE2025-04-12
10841470111790Go-PAPPULMODYNE INCBYE2025-04-12
00850071887013Emergent RespiratoryMDL Solutions IncorporatedBYE2025-04-05
00850071887136Emergent RespiratoryMDL Solutions IncorporatedBYE2025-04-05
00850071887174Emergent RespiratoryMDL Solutions IncorporatedBYE2025-04-05
46923980114340N/AGaleMed Xiamen Co., Ltd.BYE2024-09-11
B00500251DMRI0AincAANESTHESIA ASSOCIATES, INC.BYE2024-06-18