FDA UDI
In Commercial Distribution
🇺🇸 United States
APA™ MAC 3 Blade (clean, non-sterile)
DI: 08885009190028
·
Model: 700130
·
VENNER MEDICAL (SINGAPORE) PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- APA™ MAC 3 Blade (clean, non-sterile)
- Primary DI
- 08885009190028
- Version / Model
- 700130
- Catalog Number
- 700130
- Company Name
- VENNER MEDICAL (SINGAPORE) PTE. LTD.
- Labeler DUNS
- 659177273
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-22
- Public Version
- 1
- Public Version Date
- 2018-10-23
- Public Version Status
- New
- Public Device Record Key
- dcc64ee7-d0fc-436f-abde-f2ac6bccf96c
Device Description
The laryngoscope with the MAC Blade size 3 attached is used to assist routine endotracheal intubation in a similar manner to a standard Macintosh laryngoscope.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
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 |
|---|---|---|---|---|
| 46828 | Laryngoscope blade, single-use | The segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity 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 is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 28885009190022 | GS1 | Shipper Box | 20 | In Commercial Distribution | |
| Package | 18885009190025 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 08885009190028 | GS1 |