FDA UDI
In Commercial Distribution
🇺🇸 United States
Prime Series
DI: 07613327623482
·
Model: 1115
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Prime Series
- Primary DI
- 07613327623482
- Version / Model
- 1115
- Catalog Number
- 111505550004
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 078470558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-06
- Public Version
- 1
- Public Version Date
- 2024-05-14
- Public Version Status
- New
- Public Device Record Key
- 4b838d94-e03b-4737-a32d-9d7adab2aae9
Device Description
111505550004
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| FPO | STRETCHER, WHEELED | General Hospital | 880.6910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35892 | Hospital stretcher, manual | A manually-operated device consisting of a platform mounted on a wheeled frame designed primarily to facilitate easy transport of a recumbent patient within a healthcare facility; it may include side rails, supports for fluid infusion equipment, and patient securement straps. The device may also be used as a treatment table (e.g., in an emergency, recovery, or labour room), or as a bed in some intensive and specialized care units or under high patient census conditions (e.g., disasters). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327623482 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal