FDA UDI
In Commercial Distribution
🇺🇸 United States
GlideScope®
DI: 00879123006011
·
Model: Spectrum™ Smart Cable
·
Verathon Medical (Canada) ULC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GlideScope®
- Primary DI
- 00879123006011
- Version / Model
- Spectrum™ Smart Cable
- Catalog Number
- 0800-0543
- Company Name
- Verathon Medical (Canada) ULC
- Labeler DUNS
- 243738320
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 1f89ffb3-3500-4ba2-af68-4eb7d1c52073
Device Description
GlideScope® Spectrum™ Smart Cable
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCW | Laryngoscope, Rigid | Anesthesiology | 868.5540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47487 | Electrical-only medical device connection cable, reusable | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10879123006018 | GS1 | Case | 1 | In Commercial Distribution | |
| Primary | 00879123006011 | GS1 |