FDA UDI
In Commercial Distribution
🇺🇸 United States
Patient Controlled Epidural Analgesia Device (PCEA)
DI: 09350902000310
·
Model: PCEA
·
GO MEDICAL INDUSTRIES PTY. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Patient Controlled Epidural Analgesia Device (PCEA)
- Primary DI
- 09350902000310
- Version / Model
- PCEA
- Catalog Number
- PCIEPRE15
- Company Name
- GO MEDICAL INDUSTRIES PTY. LTD.
- Labeler DUNS
- 757634266
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-18
- Public Version
- 4
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- b2f4ac28-dfca-4c5c-b0bc-f13b028a0495
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61732 | Ambulatory non-insulin infusion pump, mechanical, single-use | A portable, non-electric, mechanically-powered device designed to be operated by healthcare professionals for dispensing a single dose of fluid medication [e.g., for antibiotic therapy, chemotherapy, patient-controlled analgesia (PCA)]. It consists of an empty reservoir intended to be filled with medication, a flow-rate regulator and a non-sterile (sterilizable) administration line intended to be connected to an infusion catheter (not included) for intravenous (IV), subcutaneous, intramuscular, or epidural administration. It may include flow and fluid level mechanical indicators and may be worn by the patient within and outside healthcare settings. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 09350902000334 | GS1 | Shipping carton | 30 | In Commercial Distribution | |
| Primary | 09350902000310 | GS1 | ||||
| Package | 09350902000327 | GS1 | Carton | 5 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K972158 | 000 |