FDA.reportPublic FDA data

Securmeter Foley Manometer

Primary DI
08032248471030
Brand
Securmeter Foley Manometer
Company
DELTA MED SPA
Model
HM004
Device description
Inta-abdominal pressure measuring system
Published
2025-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FENDevice, Cystometric, Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FENDevice, Cystometric, HydraulicGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38032248471031PackageGS120In Commercial Distribution
58032248471035PackageGS124In Commercial Distribution
08032248471030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803224847103138032248471031
5803224847103558032248471035
08032248471030080322484710308032248471030

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length103Centimeter
Outer Diameter6.8Millimeter

Regulatory Flags#

DUNS number
444776777
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08032248487123AtmosUD-462152025-09-02
08032248487147AtmosUD-A582452025-09-02
08032248487185Infusion SetMMT11732025-09-02
08032248490130AtmosUD-AELN2025-09-02
38032248487124AtmosUD-462152025-09-02
08032248487130AtmosUD-A362052025-09-02
38032248487148AtmosUD-A582452025-09-02
38032248487186Infusion SetMMT11732025-09-02
38032248490131AtmosUD-AELN2025-09-02
38032248471031Securmeter Foley ManometerHM0042025-05-19
08032248127401NA12T74002016-09-23
08032248007123SOL CARE T SIV0012021-03-30
08032248007130SOL CARE T SIV0022021-03-30
08032248007147SOL CARE T SIV0032021-03-30
08032248007154SOL CARE T SIV0042021-03-30
08032248007161SOL CARE T SIV0052021-03-30
08032248007178SOL CARE T SIV0062021-03-30
08032248007185SOL CARE T SIV0072021-03-30
08032248007192SOL CARE T SIV0082021-03-30
08032248007208SOL CARE T SIV0092021-03-30

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Primary DI, Brand, Company table
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006278250005742-Way Stop CockLaborie Medical Technologies Canada ULCFEN2020-10-02
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10627825010365Tubing, Extension Line, Clear, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010372Tubing, Extension Line, Blue for Pves, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010389Tubing, Extension Line, Red for Pabd, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010396Tubing, Extension Line, Yellow for Pura, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010402Tubing, Extension Line, 2 Set, Blue/Red, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010419Tubing, Extension Line, 3 Set, Blue/Red/Yellow, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010426Pump Guard / Dampening chamberLaborie Medical Technologies Canada ULCFEN2017-10-01
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10627825010464Catheter, Pabd, Single Lumen, Closed Balloon, Latex, 12FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010471Catheter, Pabd, Single Lumen, Closed Balloon, Silicone, 12FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010488Catheter, Pabd, Single Lumen, Split Balloon, PVC , Introducer 4.5FrLaborie Medical Technologies Canada ULCFEN2017-10-01
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10627825010501Catheter, Pves & Vinf, Dual Lumen, 6FrLaborie Medical Technologies Canada ULCFEN2017-10-01
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