FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 30885632125939
·
Model: SPCT1002
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 30885632125939
- Version / Model
- SPCT1002
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2020-09-23
- Public Version
- 1
- Public Version Date
- 2020-10-01
- Public Version Status
- New
- Public Device Record Key
- a800ffe4-6ec5-4aba-9537-8d8c2593d7e9
Device Description
Bag Sponge Counter Blue Back 10 Or 5 Pockets Not Made With Natural Rubber Latex MediChoice
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| LWH | Counter, sponge, surgical | General Hospital | 880.2740 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64548 | Surgical sponge-counting bag | A device in the form of a bag intended to be used in the operating room (OR) to store and maintain the count of surgical sponges/swabs during a surgical procedure to prevent these items from being inadvertently left in a patient. It is a bag with individual pockets/sections and is typically hung on an associated rack (not included); it may be weighed following sponge/swab collection to calculate blood loss. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885632125933 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 30885632125939 | GS1 | ||||
| Unit of Use | 10885632125935 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place, free from direct sunlight
- Type
- Special Storage Condition, Specify