FDA UDI
In Commercial Distribution
🇺🇸 United States
Ambu® SureSight® Connect
DI: 05707480159383
·
Model: 390511000
·
Ambu A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ambu® SureSight® Connect
- Primary DI
- 05707480159383
- Version / Model
- 390511000
- Catalog Number
- 390511000
- Company Name
- Ambu A/S
- Labeler DUNS
- 305682023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-14
- Public Version
- 2
- Public Version Date
- 2026-01-30
- Public Version Status
- Update
- Public Device Record Key
- 2bb4d6cc-0346-48d1-8234-7fb3b5a4ce0f
Device Description
Reusable Video Laryngoscope Adapter
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
- Yes
- 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 | 05707480159390 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 05707480159383 | GS1 |
Customer Contacts
- Phone
- +1(410)768-6464
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 80 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal