FDA UDI
In Commercial Distribution
🇺🇸 United States
Vermed
DI: 00009336002245
·
Model: MRN 9100-026-52
·
GRAPHIC CONTROLS ACQUISITION CORP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Vermed
- Primary DI
- 00009336002245
- Version / Model
- MRN 9100-026-52
- Catalog Number
- 32026954
- Company Name
- GRAPHIC CONTROLS ACQUISITION CORP
- Labeler DUNS
- 002111896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-23
- Public Version
- 1
- Public Version Date
- 2018-10-24
- Public Version Status
- New
- Public Device Record Key
- b41b39f8-92af-4a03-a171-9790a325801f
Device Description
Electrocardiographic recording paper
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
- 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 |
|---|---|---|---|---|
| DSF | Recorder, Paper Chart | Cardiovascular | 870.2810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16754 | Electrocardiographic recording paper | A device prepared from a thin sheet of fibrous material, typically with preprinted graphics and designed for recording the output of an electrocardiograph (ECG), or other device, in the form of measured physiologic parameters as an electrocardiogram (ECG). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50009336002240 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 00009336002245 | GS1 |
Customer Contacts
- Phone
- 800-669-6905
- [email protected]