FDA UDI
In Commercial Distribution
🇺🇸 United States
CUSTOMED
DI: M20890031060
·
Model: 712057143106
·
CUSTOMED INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- CUSTOMED
- Primary DI
- M20890031060
- Version / Model
- 712057143106
- Catalog Number
- 9003106
- 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
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a5275ef8-5773-41f9-a3b5-930a646b8e7f
Device Description
NEBULIZER SET 6CC (ML) W/PEDIATRIC MASK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | 868.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31309 | Nebulizing system delivery set, single-use | A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M20890031060 | HIBCC | ||||
| Package | M20890031062 | HIBCC | 50/CS | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- 787-622-5151
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091272 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 6 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Use following the recommendations of qualified professional.
- 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.