FDA UDI
In Commercial Distribution
🇺🇸 United States
MINISPACER
DI: 00383480000259
·
Model: 1534
·
THAYER MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MINISPACER
- Primary DI
- 00383480000259
- Version / Model
- 1534
- Catalog Number
- 1543
- Company Name
- THAYER MEDICAL CORPORATION
- Labeler DUNS
- 626238844
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b9c91121-9c15-47eb-af62-a8e1471e3177
Device Description
DUAL SPRAY MDI ADAPTER WITH 15MM O.D. X 15MM I.D. CONNECTIONS
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | 868.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35122 | Metered dose inhaler | A hand-held device designed to administer a pre-measured dose of aerosolized medication directly into the mouth of a patient. It typically consists of a shaped plastic holder with integrated mouthpiece into which a pressurized metal canister containing the solution or suspension of medicine is placed. Commonly known as a metered dose inhaler (MDI), aerosol inhaler or puffer, it is a portable device typically carried in the pocket or a handbag (purse) of the patient for convenient access. A medicine chamber spacer may be attached to this device to facilitate its use by small children (enables the slow inhalation of the medicine). This is a reusable device intended for single-patient use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10383480000256 | GS1 | CASE | 50 | In Commercial Distribution | |
| Primary | 00383480000259 | GS1 |
Customer Contacts
- Phone
- 1-800-250-3330
- [email protected]