Bard® Intra-abdominal Pressure Monitoring Device

Primary DI
10801741121095
Brand
Bard® Intra-abdominal Pressure Monitoring Device
Company
C. R. Bard, Inc.
Model
IAP001
Catalog number
IAP001
Device description
Bard Intra-abdominal Pressure Monitoring Device
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PHUIntra-abdominal pressure monitoring device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHUIntra-Abdominal Pressure Monitoring DeviceUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741121095PackageGS110In Commercial Distribution
00801741121098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174112109510801741121095
00801741121098008017411210988017411210980801741121098

GMDN Terms#

Term, Definition table
TermDefinition
Intra-abdominal pressure measurement set, mechanicalA collection of devices designed to measure intra-abdominal pressure (IAP) through the bladder. It typically includes a tube with graduated markings in mm Hg (manometer tube), clamps, a filter, and a urine collection bag. The assembled device is connected to an indwelling urethral catheter (Foley), and IAP is measured by the manometer tube based on urine level in the tube. It is typically used to measure IAP in patients at risk of intra-abdominal hypertension (IAH) such as following abdominal surgery, abdominal trauma, ventilated patients with organ dysfunction, and patients suspected of abdominal compartment syndrome (ACS). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags#

DUNS number
016898496
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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00801741076053Catheter Stabilization DeviceVFDSSPVFDSSP2020-09-22
00801741076077Catheter Stabilization DeviceFOL0100FOL01002020-09-22
00801741076091Catheter Stabilization DeviceFOL0101FOL01012020-09-22
00801741076114Catheter Stabilization DeviceFOL0102FOL01022020-09-22
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00801741137426Bard® Wide Leg Bag Straps1622101622102018-02-06
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00801741215902StatLock UrologicalSTATURO25STATURO252020-10-23
00801741231025PureWickPW300PCPW300PC2026-05-07
00801741234514PureWickPWA300HPWA300H2026-05-07
00801741225239Elyra708200170820012026-05-06
00801741225246Elyra708200270820022026-05-06
00801741231537PureWickPWKIT03HPWKIT03H2026-05-06
10801741239219PureWickPWF030KXSPWF030KXS2026-05-05

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Primary DI, Brand, Company table
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00860003478721TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESPHU2024-07-06
00860003478745TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESPHU2024-07-06
00860003478752TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESPHU2024-07-06
00860011933106TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESPHU2024-07-06
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00850019755114Accuryn SmartFoley IAP UO Temp Tray System 14FrPOTRERO MEDICAL, INC.PHU2023-03-30
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00850019755237Accuryn Monitor Mount with ClampPOTRERO MEDICAL, INC.PHU2022-10-19
00850019755244Accuryn Monitor High MountPOTRERO MEDICAL, INC.PHU2022-10-19
00850019755251Accuryn Monitor High Mount & Floor StandPOTRERO MEDICAL, INC.PHU2022-10-19
00850019755121Accuryn SmartFoley IAP UO Temp Tray System 16FrPOTRERO MEDICAL, INC.PHU2021-09-29
00868475000235Accuryn MonitorPOTRERO MEDICAL, INC.PHU2018-01-22
00801741121098Bard® Intra-abdominal Pressure Monitoring DeviceC. R. Bard, Inc.PHU2016-09-07