FDA UDI
In Commercial Distribution
🇺🇸 United States
BAM
DI: 10603354130439
·
Model: REV00
·
EHOB INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BAM
- Primary DI
- 10603354130439
- Version / Model
- REV00
- Catalog Number
- Z0156A1
- Company Name
- EHOB INC
- Labeler DUNS
- 150600252
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-03
- Public Version
- 2
- Public Version Date
- 2026-03-10
- Public Version Status
- Update
- Public Device Record Key
- 223d7e43-c5ff-4081-9f99-507ee046056d
Device Description
EHOB Air Pump
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| FMR | Device, Transfer, Patient, Manual | General Hospital | 880.6785 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37165 | Patient transfer/turning sheet, single-use | A manual device in the form of a non-inflatable sheet or mat intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10603354130439 | GS1 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 38 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius