FDA UDI
In Commercial Distribution
🇺🇸 United States
Getinge Assured Mini Bowie-Dick Test Pack
DI: 00814434020264
·
Model: 61301606667
·
STERITEC PRODUCT MFG. CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Getinge Assured Mini Bowie-Dick Test Pack
- Primary DI
- 00814434020264
- Version / Model
- 61301606667
- Catalog Number
- 61301606667
- Company Name
- STERITEC PRODUCT MFG. CO., INC.
- Labeler DUNS
- 622223196
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- 0761e54d-7ef4-450c-a889-d54d02f1d390
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35362 | Chemical/physical sterilization process indicator | A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20814434020268 | GS1 | Case | 1 | In Commercial Distribution | |
| Package | 10814434020261 | GS1 | Bag | 30 | In Commercial Distribution | |
| Primary | 00814434020264 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132372 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 38 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 70 Percent (%) Relative Humidity