FDA UDI
In Commercial Distribution
🇺🇸 United States
CUSTOMED
DI: M208CUS140
·
Model: 152570148314
·
CUSTOMED INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- CUSTOMED
- Primary DI
- M208CUS140
- Version / Model
- 152570148314
- Catalog Number
- CUS14
- Company Name
- CUSTOMED INC
- Labeler DUNS
- 627572217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2020-04-20
- Public Version Status
- Update
- Public Device Record Key
- f79a1e32-0e40-46a0-8472-72d21e125e85
Device Description
SUCTION CATHETER 14FR
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
- Yes
- 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 | M208CUS140 | HIBCC | ||||
| Package | M208CUS141 | HIBCC | 100/BOX | 100 | In Commercial Distribution | |
| Package | M208CUS142 | HIBCC | 100/BOX, 10BOX/CS | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 787-622-5151
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 14 FR |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid excessive heat and direct sunlight.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a clean, fresh, dry place.