Air Assist
- Primary DI
- 00860012876808
- Brand
- Air Assist
- Company
- GASTRO CONCEPTS LLC
- Model
- 1
- Published
- 2025-03-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| FER | Anoscope And Accessories |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FER | Anoscope And Accessories | Gastroenterology, Urology | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K242668 | 000 | Gastro Concepts Air Assist | Gastro Concepts, LLC | 2024-12-13 | FER |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00860012876808 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Colonoscope distal anchoring cuff | A device in the form of a cuff with concentric finger-like components intended to fit to a flexible colonoscope distal end to stabilize its tip within the colonic lumen and straighten the colonic folds to facilitate observation and/or surgical instrument use. The fingers are intended to open and grip the colon during pull back (exturbation); the device may in addition have a protruding distal end (spacer) intended to maintain distance between the endoscope tip and structures of interest. This is a single-use device. |
Regulatory Flags
- DUNS number
- 119470806
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 18051887044730 | THD N-Ano anoscope | THD SPA | FER | 2025-03-14 |
| 18051887044754 | THD N-Ano Anoscope | THD SPA | FER | 2025-03-14 |
| 08033638801192 | Adaptor | SAPI MED SPA | FER | 2023-08-02 |
| 08033638800447 | Self-light anoscopes | SAPI MED SPA | FER | 2023-07-27 |
| 08033638803585 | Self-light anoscopes | SAPI MED SPA | FER | 2023-07-27 |
| 08033638801260 | Self-light anoscopes | SAPI MED SPA | FER | 2023-07-27 |
| 08033638801369 | Epoflier | SAPI MED SPA | FER | 2023-07-27 |
| 08033638802892 | Self-light anoscopes | SAPI MED SPA | FER | 2023-07-27 |
| 00732094007657 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2023-04-27 |
| 00732094239331 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2023-04-25 |
| 04053755200436 | INSTRUMENT HEAD FOR UNISPEC TUBES | Heine Optotechnik GmbH & Co. KG | FER | 2023-01-11 |
| 00732094007626 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-05-07 |
| 00732094128208 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-05-07 |
| 00732094007664 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-26 |
| 00732094009828 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-26 |
| 00732094007541 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-15 |
| 00732094007602 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-15 |
| 00732094007633 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-15 |
| 00732094007640 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-15 |
| 00732094009736 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-15 |
| 00732094009743 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-15 |
| 00732094009750 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-15 |
| 00732094009767 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-15 |
| 00732094009774 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-15 |
| 00732094009804 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-15 |
| 00732094009811 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-15 |
| 00732094128178 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-15 |
| 00732094128222 | Welch Allyn, Inc. | WELCH ALLYN, INC. | FER | 2021-04-15 |
| 40612479198539 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | FER | 2020-06-09 |