FDA UDI
In Commercial Distribution
🇺🇸 United States
Bleed ID
DI: G8057116571
·
Model: Suction Pad
·
APARATA MEDICAL, LLC
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bleed ID
- Primary DI
- G8057116571
- Version / Model
- Suction Pad
- Catalog Number
- 711657
- Company Name
- APARATA MEDICAL, LLC
- Labeler DUNS
- 044706132
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-02
- Public Version
- 1
- Public Version Date
- 2026-03-10
- Public Version Status
- New
- Public Device Record Key
- 5b6637de-75c8-432b-a1ed-6a9cc0e76b12
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16779 | Suction/irrigation tubing, single-use | A length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device. | No | Active |
| 67644 | Blood loss estimation suction pad | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G8057116571 | HIBCC |
Customer Contacts
- Phone
- 4079174731
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 32 | Inch | |
| Width | 32 | Inch |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius