FDA UDI
In Commercial Distribution
🇺🇸 United States
AMD-RITMED
DI: 10686864042799
·
Model: 2214
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- AMD-RITMED
- Primary DI
- 10686864042799
- Version / Model
- 2214
- Catalog Number
- 2214
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2019-01-16
- Public Version
- 3
- Public Version Date
- 2022-07-29
- Public Version Status
- Update
- Public Device Record Key
- 7255f7d5-a183-41c6-b798-37012f7a98c2
Device Description
AMD-RITMED COUNTWAY INNER BAGS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LWH | Counter, sponge, surgical | General Hospital | 880.2740 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61453 | Surgical sponge-counting tray | A device in the form of a tray intended to be used in the operating room (OR) to store and maintain the count of surgical sponges/swabs during a surgical procedure, typically to prevent these items from being inadvertently left in a patient. It is a tray with individual sections; 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 | 20686864042796 | GS1 | Outer Case | 8 | In Commercial Distribution | |
| Primary | 10686864042799 | GS1 | ||||
| Unit of Use | 00686864042792 | GS1 |
Customer Contacts
- Phone
- +1(514)636-6262 ext. 2309
- [email protected]
- Phone
- +1(514)636-6262
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool dry place