FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE INDUSTRIES, INC.
DI: 10888277100152
·
Model: HCS2GONB
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MEDLINE INDUSTRIES, INC.
- Primary DI
- 10888277100152
- Version / Model
- HCS2GONB
- Catalog Number
- HCS2GONB
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-09
- Public Version
- 2
- Public Version Date
- 2022-11-21
- Public Version Status
- Update
- Public Device Record Key
- f1dc729c-a1ee-431c-840f-718b27e3918d
Device Description
COMPRESSOR,NEBULIZER, PORTABLE
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTI | Compressor, air, portable | Anesthesiology | 868.6250 | 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 | 10888277100152 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031413 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry. Shield from direct sunlight. Avoid excessive heat-Protect from freezing.