FDA UDI
In Commercial Distribution
🇺🇸 United States
Fetal Measurements
DI: 20884838116508
·
Model: REUSABLE ABDOMINAL BELT- 60MM WD,1.3M LG
·
Philips Medizin Systeme Böblingen GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- Fetal Measurements
- Primary DI
- 20884838116508
- Version / Model
- REUSABLE ABDOMINAL BELT- 60MM WD,1.3M LG
- Catalog Number
- M4602A
- Company Name
- Philips Medizin Systeme Böblingen GmbH
- Labeler DUNS
- 314101143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2025-01-24
- Public Version
- 2
- Public Version Date
- 2025-12-08
- Public Version Status
- Update
- Public Device Record Key
- f55aa61d-90ab-41d0-8405-b495c19fb295
Device Description
Latex-Free Reusable abdominal belt with button holes. Gray, elastic, washable. Pre-cut. Water- resistant. 5 belts. Length = 4 1/4 ' (1.3m) Width = 2 3/8" (60mm)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| HGM | System, Monitoring, Perinatal | Obstetrics/Gynecology | 884.2740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35709 | Electrode/transducer strap, reusable | A strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00884838003231 | GS1 | ||||
| Primary | 20884838116508 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 65 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 149 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 80 Percent (%) Relative Humidity