Product Specifications
| Specification | Box Configuration (BX) | Case Packaging (CS) |
| Manufacturer / Brand | Welch Allyn (Hillrom / Baxter) / KleenSpec® | Welch Allyn (Hillrom / Baxter) / KleenSpec® |
| Manufacturer SKU / Item # | 59004-LED | 59004-LED |
| GMDN / UNSPSC Code | 42141702 | 42141702 |
| Size / Sizing Color Code | Large / Pink Handle | Large / Pink Handle |
| Material Formulation | Clear Smooth Acrylic (Latex-Free) | Clear Smooth Acrylic (Latex-Free) |
| Blade / Style Type | Double-Blade Duckbill (Pederson / Graves Style) | Double-Blade Duckbill (Pederson / Graves Style) |
| Illumination System | Integrated Cordless LED (Self-Powered / Pull-Tab Activation) | Integrated Cordless LED (Self-Powered / Pull-Tab Activation) |
| Sterility Status | Non-Sterile / Single-Use Disposable | Non-Sterile / Single-Use Disposable |
| Storage Temperature | Ambient Controlled Room Temperature | Ambient Controlled Room Temperature |
| Packaging Configuration | 14 Specula per Box (BX) | 56 Specula per Case (4 Boxes of 14) |
| Regulatory Category | FDA Class II Medical Device / Prescription (Rx) | FDA Class II Medical Device / Prescription (Rx) |
| CPT Code | 99211–99215 (Exam Adjunct) | 99211–99215 (Exam Adjunct) |
Key Features & Clinical Applications
-
Integrated Cordless LED Light: Self-contained, single-use LED light source provides uniform, shadow-free illumination while eliminating capital equipment costs and cord management.
-
Pull-Tab Instant Activation: Built-in pull-tab system powers the LED light instantly upon removal, ensuring continuous bright white light output throughout the pelvic examination.
-
Expanded Anatomical Access: Wider and deeper blade dimensions designed specifically for clear visualization and tissue isolation in multiparous patients or complex pelvic exams.
-
Complete Canal Visualization: Precision-molded clear acrylic structure allows an unobstructed 360° illuminated view of the vaginal mucosa and cervix.
-
Workflow Optimization: Completely self-powered single-use format speeds up exam room turnover, eliminates cord clutter, and removes reprocessing bottlenecks.
⚠️ Single-Patient Use & Battery Notice: Single-use disposable device containing an embedded single-use battery power source. Do not attempt to re-sterilize, recharge, or reuse. Dispose of in accordance with facility policies for electronic medical waste.
⚠️ Activation Protocol: Pull the activation tab immediately prior to insertion to ensure maximum LED brightness and continuous battery longevity throughout the examination.
