FDA UDI
In Commercial Distribution
🇺🇸 United States
ri-integral set Miller LED 2.5 V with C-handle
DI: 04045396168305
·
Model: 8061
·
Rudolf Riester GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ri-integral set Miller LED 2.5 V with C-handle
- Primary DI
- 04045396168305
- Version / Model
- 8061
- Catalog Number
- 8061
- Company Name
- Rudolf Riester GmbH
- Labeler DUNS
- 537208717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-28
- Public Version
- 1
- Public Version Date
- 2021-02-05
- Public Version Status
- New
- Public Device Record Key
- 234957ed-e141-43b4-8309-4ce14f913d8e
Device Description
The laryngoscopes are manufactured in order to be used for endotracheal intubation. The Riester battery handles are used in order to supply the bulbs with energy and for fixation of the blades.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| 15076 | Rigid intubation laryngoscope, reusable | A hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04045396168305 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K945425 | 000 |