FDA UDI
In Commercial Distribution
🇺🇸 United States
Batrik First Check Scope Bag 30.5"
DI: 00690521016149
·
Model: 17-HAP30
·
Batrik Medical Manufacturing Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Batrik First Check Scope Bag 30.5"
- Primary DI
- 00690521016149
- Version / Model
- 17-HAP30
- Catalog Number
- 17-HAP30
- Company Name
- Batrik Medical Manufacturing Inc
- Labeler DUNS
- 243880700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-06
- Public Version
- 1
- Public Version Date
- 2021-12-14
- Public Version Status
- New
- Public Device Record Key
- 544da0fd-cf36-4e3b-9262-9fc46e279c6c
Device Description
Transport Bags fo Endoscope & Medical Instruments (Clean Instruments Bags), 30.5"x 26"
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 |
|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64018 | Instrument hygienic-transportation bag | A non-sterile flexible plastic container intended to collect and contain an instrument(s) [e.g., an endoscope] following an invasive procedure, for hygienic transportation of the device to a reprocessing facility. It is typically a drawstring bag/wrap which may be designed to be laid flat on the procedure tray/trolley during the procedure and then closed to contain the device; it is not a drape/cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690521016149 | GS1 |
Customer Contacts
- Phone
- 514-631-7988
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight