FDA UDI
In Commercial Distribution
🇺🇸 United States
Perma Pure
DI: 00840106901166
·
Model: ME Series
·
PERMA PURE LLC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
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Basic Information
- Brand Name
- Perma Pure
- Primary DI
- 00840106901166
- Version / Model
- ME Series
- Catalog Number
- ME-050-03-46
- Company Name
- PERMA PURE LLC
- Labeler DUNS
- 063142533
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-11
- Public Version
- 2
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- 04744de3-192e-4292-a074-b44ef23dd0a8
Device Description
12" ME W/ MALE LUERS
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
- 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 |
|---|---|---|---|---|
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | Anesthesiology | 868.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45566 | Gas-sampling/monitoring respiratory tubing, single-use | A length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840106901203 | GS1 | Inner | 50 | In Commercial Distribution | |
| Primary | 00840106901166 | GS1 | ||||
| Package | 00840106901197 | GS1 | Inner | 25 | In Commercial Distribution | |
| Package | 00840106901180 | GS1 | Inner | 10 | In Commercial Distribution | |
| Package | 00840106901173 | GS1 | Inner | 5 | In Commercial Distribution |