McGRATH MAC
Disposable Laryngoscope Blade 2
44manufacturers in China registered for this device type
32catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (22), Jiangsu (9), Zhejiang (7). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| MediConcepts Technology (Shenzhen) Company Limited | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
Showing 12 of 44. All 44 manufacturers in China registered for Laryngoscope, Rigid
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | CCW |
| Device type | Laryngoscope, Rigid |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5540 |
| Premarket notification | Exempt |
| Record published | 2025-04-27 |
| Record revised | 2026-04-28 (version 15) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Fragile, Keep dry, Stacking limitations, This side up; Storage environment temperature 14 to 158 °F |
| Packaging | Pack_or_inner_pack of 50, case of 10, pack_or_inner_pack of 10, case of 30, pack_or_inner_pack of 20, case of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 350-017-000 | In distribution | |
| 350-005-000 | In distribution | |
| 301-000-000 | In distribution | |
| 350-088-000 | In distribution | |
| 350-013-000 | In distribution | |
| 350-072-000 | In distribution | |
| 350-072-000 | In distribution | |
| 301-000-000 | In distribution | |
| 350-082-000 | In distribution | |
| 350-086-000 | In distribution | |
| 350-084-000 | In distribution | |
| 350-013-000 | In distribution | |
| 350-013-000 | In distribution | |
| 350-005-000 | In distribution | |
| 350-013-000 | In distribution | |
| 302-000-000 | In distribution | |
| 302-000-000 | In distribution | |
| DL300-000-000 | In distribution | |
| 350-072-000 | In distribution | |
| 350-086-000 | In distribution | |
| 350-017-000 | In distribution | |
| 350-017-000 | In distribution | |
| 350-005-000 | In distribution | |
| 350-072-000 | In distribution | |
| 350-084-000 | In distribution | |
| 350-005-000 | In distribution | |
| 300-000-000 | In distribution | |
| 350-017-000 | In distribution | |
| 350-088-000 | In distribution | |
| 350-013-000 | In distribution | |
| 350-082-000 | In distribution | |
| 350-005-000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 509 |
| SunMed | SunMed Group Holdings, LLC | 255 |
| Ambler Surgical | Ambler Surgical, LLC | 192 |
| AincA® | Anesthesia Associates, Inc. | 186 |
| Curaplex | Bound Tree Medical, LLC | 172 |
| GlideScope® | Verathon Medical (Canada) ULC | 166 |
| Pilling | Teleflex Medical LLC | 163 |
| Carnegie Surgical LLC | Carnegie Surgical LLC | 157 |
| Laryngoscope, Rigid | Karl Storz GmbH & Co. KG | 140 |
| Medline | Medline Industries, Inc. | 128 |
| Millennium | Avalign Technologies, Inc. | 111 |
| Sklar® | Sklar Corporation | 92 |
Showing 12 of 442. All products under Laryngoscope, Rigid
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | UDI-DI | 2024-07-09 | Class I | Device Design | Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion. | 75,544 units |
| Covidien | UDI-DI | 2023-09-28 | Class I | Process control | Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in failed laryngoscopy and/ | 5709 |
| Covidien | UDI-DI | 2023-08-10 | Class II | Under Investigation by firm | Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured. | 42,367 |
| Covidien | UDI-DI | 2023-08-10 | Class II | Under Investigation by firm | Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured. | 42,367 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.