FDA UDI
In Commercial Distribution
🇺🇸 United States
Little Sucker® and Cover
DI: 10812594010368
·
Model: Preemie
·
Neotech Products LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Little Sucker® and Cover
- Primary DI
- 10812594010368
- Version / Model
- Preemie
- Catalog Number
- N204
- Company Name
- Neotech Products LLC
- Labeler DUNS
- 198013435
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-02-20
- Public Version
- 7
- Public Version Date
- 2023-09-21
- Public Version Status
- Update
- Public Device Record Key
- 8c61f4b7-0e6d-44d1-91bc-6bdc9a0d187a
Device Description
The Little Sucker/ NeoSucker are indicated to be used as a tip for suction tubing to aspirate fluids from the mouth and nares. The Little Sucker Cover is indicated for use to protect the Little Sucker Device. The Suction Caddy is intended to hold and store a suction device.
Device Characteristics
- Single Use
- Yes
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOL | Catheter And Tip, Suction | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10749 | Airway suction catheter | A flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10812594010368 | GS1 | ||||
| Unit of Use | 00812594010361 | GS1 |