Grafco
- Primary DI
- M368339910
- Brand
- Grafco
- Company
- GF HEALTH PRODUCTS, INC.
- Model
- 3399-1
- Catalog number
- 3399-1
- Device description
- TRACH TUBE BRUSH 14" FOR 5-9
- Published
- 2021-05-10
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| EPE | Brush, Cleaning, Tracheal Tube |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EPE | Brush, Cleaning, Tracheal Tube | Anesthesiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| M368339911 | Primary | HIBCC | 0 | |
| M368339910 | Unit of Use | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Airway device cleaning utensil, noninvasive, reusable | A hand-held device intended to be used to clean an ex situ non-endoscopic airway device [e.g., endotracheal (ET) tube, tracheoesophageal speech valve, laryngeal airway], once it has been removed from the patient, to remove organic matter (e.g., phlegm). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device. |
Regulatory Flags
- DUNS number
- 132016168
- Device count
- 12
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 08904428798483 | OSSEOUS- Tube Cleaning Brush - 8mm | EON MEDITECH PRIVATE LIMITED | EPE | 2026-03-13 |
| 00848530085414 | CPAP Cleaning Kit | SUNSET HEALTHCARE SOLUTIONS, INC. | EPE | 2025-04-14 |
| 00848253004013 | Cleaning Brush, Standard | Freudenberg Medical, LLC | EPE | 2025-03-25 |
| 00848253004020 | Cleaning Brush, Long | Freudenberg Medical, LLC | EPE | 2025-03-25 |
| 00348783005110 | Premier Tracheal Tube Brush | PREMIER DENTAL PRODUCTS COMPANY | EPE | 2024-08-06 |
| 00348783005127 | Premier Tracheal Tube Brush | PREMIER DENTAL PRODUCTS COMPANY | EPE | 2024-08-06 |
| 10630094174041 | Bioseal Inc. | BIOSEAL | EPE | 2023-09-18 |
| 10630094174096 | Bioseal Inc. | BIOSEAL | EPE | 2023-09-18 |
| 07331791016493 | Provox TubeBrush 8 mm | Atos Medical AB | EPE | 2022-11-25 |
| 07331791016509 | Provox TubeBrush 12 mm | Atos Medical AB | EPE | 2022-11-25 |
| 34063107102678 | Trach Tube Cleaning Brushes | Boston Medical Products, Inc. | EPE | 2022-09-30 |
| 34063107102685 | Trach Tube Cleaning Brushes | Boston Medical Products, Inc. | EPE | 2022-09-30 |
| 34063107102692 | Trach Tube Cleaning Brushes | Boston Medical Products, Inc. | EPE | 2022-09-30 |
| 34063107102708 | Trach Tube Cleaning Brushes | Boston Medical Products, Inc. | EPE | 2022-09-30 |
| 50653160004750 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | EPE | 2022-01-01 |
| 40080196466864 | ML-CANADA | MEDLINE INDUSTRIES, INC. | EPE | 2022-01-01 |
| 16973881680047 | XinjingProWellness™ | Tianjin Newtrans Technology Development | EPE | 2021-12-24 |
| 16973881680054 | XinjingProWellness™ | Tianjin Newtrans Technology Development | EPE | 2021-12-24 |
| 16973881680061 | XinjingProWellness™ | Tianjin Newtrans Technology Development | EPE | 2021-12-24 |
| M368339920 | Grafco | GF HEALTH PRODUCTS, INC. | EPE | 2021-05-10 |
| M368339931 | Grafco | GF HEALTH PRODUCTS, INC. | EPE | 2021-05-10 |
| M36834130 | Grafco | GF HEALTH PRODUCTS, INC. | EPE | 2021-05-10 |
| B00500458L0 | AincA® | ANESTHESIA ASSOCIATES, INC. | EPE | 2021-03-31 |
| B00500458M0 | AincA® | ANESTHESIA ASSOCIATES, INC. | EPE | 2021-03-31 |
| B00500458S0 | AincA® | ANESTHESIA ASSOCIATES, INC. | EPE | 2021-03-31 |
| 30649111028575 | Sklar | SKLAR CORPORATION | EPE | 2019-07-17 |
| 30649111029107 | Sklar | SKLAR CORPORATION | EPE | 2019-07-17 |
| 50649111341869 | Sklar | SKLAR CORPORATION | EPE | 2019-07-17 |
| 24026704265163 | KMEDIC | TELEFLEX INCORPORATED | EPE | 2018-09-15 |
| 24026704265170 | KMEDIC | TELEFLEX INCORPORATED | EPE | 2018-09-15 |
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