Device
Safetywedge
Manufacturer
BIOPTIMAL INTERNATIONAL PTE. LTD.
Model: Safetywedge Catalog: 21-000212-01 DI: 08886483551664 Status: New MRI: MR Unsafe Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-20 Current Version: 2026-05-28
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: e633c9a0-c984-4cca-9924-b673dcc6b9c9
Distribution Status: In Commercial Distribution
DUNS Number: 595182247
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: Yes
Labeled No NRL: No
Identifiers
Device ID: 08886483551664
Type: Primary
Issuing Agency: GS1
GMDN
Code: 34925
Name: Pulmonary artery balloon catheter, electrical
Definition:
A flexible tube with an inflatable balloon(s) and electrical component(s) [e.g., thermistor, fibreoptic bundle] at its distal tip designed to be introduced percutaneously into the venous system via a central vein, and advanced to the pulmonary artery, to measure/monitor haematological parameters [e.g., pulmonary arterial pressures (e.g., wedge), cardiac output, cardiac index, mixed venous oxygen saturation (SvO2)]; it might use thermal dilution techniques and in addition be intended for venous blood sampling. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., blood pressure transducer) [not included]. This is a single-use device.
FDA Product Codes
KRB
Probe, Thermodilution
Environmental Conditions
Storage Handling - Storage Handling Type: Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text: Store in dark cool dry places