FDA UDI
In Commercial Distribution
🇺🇸 United States
AincA®
DI: B00500675B0
·
Model: 00-675-B
·
ANESTHESIA ASSOCIATES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AincA®
- Primary DI
- B00500675B0
- Version / Model
- 00-675-B
- Catalog Number
- 00-675-B
- Company Name
- ANESTHESIA ASSOCIATES, INC.
- Labeler DUNS
- 002065670
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-31
- Public Version
- 3
- Public Version Date
- 2025-03-06
- Public Version Status
- Update
- Public Device Record Key
- fa56b721-48de-4e03-b4c1-60957b6251d6
Device Description
AincA VideoStylet System, Model "B" stylet (length = 33.5cm / 13.2"), LCD Video Monitor, USB Charger/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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| CAL | LARYNGOSCOPE, NON-RIGID | Anesthesiology | 868.5530 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44962 | Flexible intubation laryngoscope, video, reusable | An endoscope with a flexible inserted portion intended for the visual examination of the trachea, and to assist the entry and positioning of an airway tube, typically an endotracheal (ET) tube, to secure an open airway in the case of difficult and non-difficult intubation procedures. The inserted portion is thin and long to facilitate endoscope entry and the intubation procedure. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. It is typically used during difficult and non-difficult intubation procedures when maintaining an airway open. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B00500675B0 | HIBCC |
Customer Contacts
- Phone
- +1(760)744-6561
- [email protected]