FDA.reportPublic FDA data

Bleed ID

Primary DI
G8057116571
Brand
Bleed ID
Company
APARATA MEDICAL, LLC
Model
Suction Pad
Catalog number
711657
Device description
"The Bleed ID Suction Pad is a 32""x32"" collection device intended for use in obstetrics and gynecological procedures to aid the clinician in the detection of blood loss. The Bleed ID Suction Pad is intended to be powered by a single-source vacuum and used with collection canisters."
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G8057116571PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood loss estimation suction padA flat non-absorbent synthetic polymer device with integrated fluid channels and suction tubing intended to be placed on an operating table and underneath a patient to collect blood during surgery (e.g., caesarean section) to monitor/measure blood loss. It is intended for use with a separate suction source and blood collection container. The collected blood helps a clinician to monitor and measure blood loss during the procedure. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length32Inch
Width32Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4079174731info@aparatamedical.com

Regulatory Flags#

DUNS number
044706132
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011549505SafeSplint"16"" Short Arm Splint"6000892025-09-24

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Primary DI, Brand, Company table
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