FDA UDI
In Commercial Distribution
🇺🇸 United States
Medichoice
DI: 10885632136672
·
Model: PA1010
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medichoice
- Primary DI
- 10885632136672
- Version / Model
- PA1010
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-20
- Public Version
- 5
- Public Version Date
- 2020-10-06
- Public Version Status
- Update
- Public Device Record Key
- d740b3ef-f9c7-41f3-b6bf-ed054e4f08b4
Device Description
Kit Port Access Includes 1 Tray 4 Gauze 2X2 1 Prefilled Syringe 1 Tegaderm 3.5X4.5 1 Towel White 23X24 1 Towel White Kaycel 1 Header Bag 10X15 1 Alcohol Swabstick Single 1 Skin Wipe 1 Chloraprep 1 Card Tape Strips 1 Hand Sanitizer 1 Label 1 Mask Sterile Not Made With Natural Rubber Latex MediChoice
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KKX | Drape, surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61345 | Arterial/central venous catheterization support/maintenance kit, non-medicated | A collection of devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885632136670 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 10885632136672 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K921394 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius